Obesity and OverweightPRECINUTNCT06923644
Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases
A study testing Optimal Metabotype-specific diet and Sub-optimal diet in people with Obesity and Overweight and Pre-diabetic, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
Nutrition is very important to keep blood sugar levels balanced. If blood sugar levels are too high, it can lead to diseases such as cardiovascular disease and type 2 diabetes (T2DM). Therefore, adjusting what one eats, also called a diet or nutritional intervention, can help prevent these diseases. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight, Pre-diabetic, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Optimal Metabotype-specific diet and Sub-optimal diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesNetherlands
- Study dates
- 23 Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women with a BMI ≥25 to <40 kg/m2
- Classification possible to one of the investigational metabolic phenotypes according to the classification algorithm.
- Weight stability for at least 3 months (+/- 3 kg)
Who cannot join
- Diseases
- (Pre-)diagnosis of type 1 or type 2 diabetes mellitus (i.e., FPG ≥ 7,0 mmol/L) and HbA1c ≥ 6,5% (48 mmol/mol)
- Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT and creatinine values)
- Gastrointestinal diseases or abdominal surgery (allowed i.e.:
- appendectomy, cholecystectomy)
- Food allergies, intolerances (including gluten/lactose intolerance) and/or eating disorders interfering with the study
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- Cardiovascular diseases (e.g., heart failure) or cancer (e.g., noninvasive skin cancer allowed)
- High systolic blood pressure (untreated >160/100 mmHg, drug-regulated >140/90 mmHg)
- Diseases affecting glucose and/or lipid metabolism (e.g., pheochromocytoma, Cushing's syndrome, acromegaly)
- Diseases with a life expectation shorter than 5 years
- Major mental disorders
- Drug treated thyroid diseases (well substituted hypothyroidism is allowed inclusion)
- Other physical/mental conditions that may interfere with study outcomes
- Medication
- Medication known to interfere with study outcomes (e.g., PPAR-α or PPAR-γ agonists (fibrates), sulfonylureas, biguanides, α-glucosidaseinhibitors, thiazolidinediones, repaglinide, nateglinide, insulin, and chronic use of NSAIDs)
- Use of certain anticoagulants other than acetylsalicylic acid
- Use of antidepressants (stable use ≥ 3 months prior to and during study allowed)
- Use of statins (stable use ≥ 3 months prior to and during study allowed)
- Chronic corticosteroids treatment (>7 consecutive days of treatment)
- Use of antibiotics within 3 months prior to the study
- Lifestyle
- Participation in regular sports activities (moderate-to-vigorous physical exercise >4 hours per week)
- Having a restricted dietary pattern interfering with the study diets (e.g., vegetarian, vegan, Atkins diet and/or other special diets)
- Plans to lose or gain more than 5% body weight
- Abuse of alcohol (alcohol consumption >14 units/week) and/or drugs (cannabis included)
- Not willing to limit alcohol consumption to 7 drinks per week
- Regular smoking (including use of e-cigarettes and vapes)
- Use of strong vitamins or other dietary supplements (e.g., pre- or probiotics) expected to interfere with the study outcomes
- Other
- Metabotype classification is not possible
- Pregnant or lactating women, or women who are planning to become pregnant
- Inability to comply with the study diet
- Blood donation within the last 3 months
- Participation in possibly interfering studies within the last 3 months
- Inability to understand study information and/or communicate with staff
- Unwillingness to be randomised or sign informed consent
- Unwillingness to save data for 15 years
- Deemed unsuitable for participation in the trial, for any reason, as judged by the research physician or principal investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Maastricht University Medical Center, Department of Human Biology, NUTRIM Institute of Nutrition and Translational Research in Metabolism
Maastricht, 6200MD
Ellen E Blaak, Prof. Dr. Ir., +31433881503, e.blaak@maastrichtuniversity.nl
Art Muijsenberg, MSc, +31433882862, art.muijsenberg@maastrichtuniversity.nl
- Recruiting
Wageningen University and Research, Division of Human Nutrition
Wageningen, 6700AA
Lydia A Afman, Prof. Dr. Ir., +31(0)31 74 85789, lydia.afman@wur.nl
Milena Banic, PhD, +31618713321, milena.banic@wur.nl
About this study
Nutrition is very important to keep blood sugar levels balanced. If blood sugar levels are too high, it can lead to diseases such as cardiovascular disease and type 2 diabetes (T2DM). Therefore, adjusting what one eats, also called a diet or nutritional intervention, can help prevent these diseases. However, not everyone responds the same to a diet. In about 30% of people, a diet does not work as hoped. This can be due to various reasons, such as a person's metabolism, genetic predisposition, the composition of the food one eats, or the bacteria in the intestines. Everyday things like sleep, stress, and movement also play a role. The investigators used a computer model to classify people with overweight and obesity into groups based on these factors. The investigators call such a group a 'Metabolic Phenotype', or in short 'Metabotype'. Based on the Metabotype, a personalised diet was developed (personalised nutrition intervention) that may better suit each person's unique situation.
The investigators hypothesize that a precision nutrition intervention, tailored to Metabotypes identified through unsupervised clustering (using the aforementioned computer model) of predefined, accurate features related to cardiometabolic health-specifically, tissue-specific glucose and lipid metabolism and detailed body composition-will enhance blood glucose homeostasis, reduce cardiometabolic risk, and improve adherence to the intervention and mental well-being, compared to population-based dietary guidelines. The present project will contribute to targeted and efficient precision-based dietary strategies for individuals at increased risk of T2DM.
Read the detailed description
Objective:
Our study aims to identify unique Metabotypes among individuals with overweight and obesity and assess their response to a 1-year precision dietary macronutrient modulation. The objective is to provide proof-of-concept that this approach improves glucose homeostasis, dietary adherence, and psychosocial well-being compared to population-based dietary guidelines.
Study design:
Two-centre dietary intervention study with a double-blind, randomised controlled parallel design, based on participants' Metabotype and hypothesized optimal diet. Participants' Metabotype and intervention arm will be blinded to the participants and researchers. Metabotypes were identified through hierarchical clustering of Principal Components (HCPC) using baseline data from The Maastricht Study (participant demographics, body composition, glucose- and insulin metabolism), whereafter clusters were cross-validated in independent cohorts. Based on a combination of post-hoc analyses of dietary intervention trials and literature, the optimal dietary macronutrient composition was determined for these Metabotypes.
Study population:
In total 240 men and women with overweight and obesity (age 40-75 years, BMI 25-40 kg/m2) will be included. Further details on in- and exclusion criteria will be described under ''Eligibility''. Following screening and baseline measurements, for each eligible participant, a classification algorithm will determine the participants' Metabotype cluster (one of three possible Metabotypes for each sex).
Intervention:
Following screening, baseline measurements, and determination of Metabotype, participants will be randomly assigned, using minimization, to either the Precision Nutrition (PN) group or the Control (CN) group. The PN group will receive a hypothesized optimal diet for their specific Metabotype, while the control group will be randomly assigned one of the diets optimized for a different Metabotype of the same sex. All participants will follow their assigned diets for 12 months, with each diet conforming to the Dutch healthy dietary guidelines. Participants will receive regular dietary consultation, and meal plans including variation lists to guide them with their dietary intake during the intervention.
Main study parameters/endpoints:
Extensive characterization will be done before, during, and after the intervention. Primary outcome measure is whole-body insulin sensitivity (Matsuda index) assessed by means of a 7-point oral glucose tolerance test (OGTT). Secondary outcomes include glycaemic variability, mean glucose levels, fasting lipid profiles, body composition, blood pressure, gene and protein expression of adipose tissue, microbial composition and functionality, metabolomics, physical activity, adherence to dietary recommendations, (mental) well-being, and quality of life.
- Being tested
- Optimal Metabotype-specific diet, Sub-optimal diet
- Keywords
- Dietary intervention trial, Precision nutrition, Tissue-specific insulin resistance, Body composition, Metabotyping, Glucose homeostasis, Cardiometabolic health, Insulin resistance, Metabolic phenotype
- Medical subject headings
- Obesity, Overweight, Glucose Intolerance, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal Metabotype-specific dietOther
Following screening, baseline measurements, and determination of Metabotype, participants will be randomly assigned, using minimisation, to either the Precision Nutrition (PN) group or the Control (CN) group. The PN group will receive a diet hypothesised to be optimal for their specific Metabotype. All participants will adhere to their assigned diets for 12 months. Each Metabotype-specific diet will align with the Dutch Healthy Dietary Guidelines, while varying in macronutrient composition and quality.
Sub-optimal dietOther
Participants randomised to the Control Group (CN), will be randomly assigned one of the two diets optimised for a different Metabotype of the same sex. The assigned CN Group diet will always have a macronutrient content and quality that is different than their hypothesised optimal diet. All diets will align with the Dutch Healthy Dietary Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Precision Nutrition Group (PN) | Experimental | For a total duration of 12 months, participants in the Precision Nutrition (PN) Group will follow a diet tailored to their Metabotype, which is hypothesised to be optimal for them. Receives: Other: Optimal Metabotype-specific diet |
| Control Group (CN) | Experimental | For a total duration of 12 months, participants in the Control Group (CN) will be randomly assigned one of the diets optimised for a different Metabotype of the same sex, which is hypothesised to be suboptimal for them. Receives: Other: Sub-optimal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matsuda Index
The primary objective of this study is to evaluate the effect of a 12-month Metabotype-targeted diet (PN) versus a non-targeted diet (CN) on whole-body insulin sensitivity (Matsuda Index; marker of whole-body fasting and postprandial insulin sensitivity). This will include within group post-hoc testing. The primary outcome measure will be assessed by means of a 7-point oral glucose tolerance test (OGTT), and calculated as follows: [10,000 / square root of [fasting plasma glucose (mg/dL) × fasting insulin (mU/L)] × [mean glucose (mg/dL) x mean insulin (mU/L)]].
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Secondary outcomes (46)
Glucose tolerance
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Determined by 2-hour plasma glucose values (mmol/L) during an oral glucose tolerance test (OGTT).
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Disposition Index (DI)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. The Disposition Index is a composite marker of first phase insulin secretion and insulin sensitivity during a 2-hour 7-point oral glucose tolerance test (OGTT). Disposition index will be calculated as follows: [Insulin sensitivity index (ISI) * (AUC30 min insulin / AUC30 min glucose)], where AUC30 min is the area under the curve between 0 and 30 minutes of the OGTT for insulin (pmol/l) and glucose (mmol/l), respectively, and ISI is defined as: [10,000 ÷ square root of (fasting plasma glucose (mmol/l) x fasting insulin (pmol/l)) x (mean glucose (mmol/l) x mean insulin (pmol/l))]. Higher values represent a higher insulin sensitivity.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
HOMA-IR
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. HOMA-IR is a fasting measure for insulin resistance, which can be calculated as follows: HOMA-IR = (Fasting plasma glucose (mmol/L) * Fasting Insulin (mU/L)) / 22.5. Higher values represent a higher degree of insulin resistance. Determined in plasma during a 2-hour, 7-points oral glucose tolerance test (OGTT).
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Muscle insulin sensitivity (MISI)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Determined during a 2-hour, 7-point oral glucose tolerance test (OGTT). The muscle insulin sensitivity index (MISI) will be calculated as follows: MISI (mmol/l/min/pmol/l) = (dG/dt) / mean plasma insulin concentration (pmol/l) during OGTT. Here, dG/dt is the rate of decay of plasma glucose concentration (mmol/L) during the OGTT, calculated as the slope of the least square fit to the decline in plasma glucose concentration from peak to nadir. Higher values represent higher muscle insulin sensitivity.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Hepatic insulin resistance (HIRI)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Determined during a 2-hour, 7-point oral glucose tolerance test (OGTT). The hepatic insulin resistance index (HIRI) will be calculated using the square root of the product of the area under curves (AUCs) for plasma glucose and insulin during the first 30 min of the OGTT - i.e., square root (glucose0-30 [AUC in mmol/l·h] · insulin 0-30 [AUC in pmol/l·h). Higher HIRI values represent lower hepatic insulin sensitivity.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Adipose tissue insulin sensitivity (ATIRI)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. The Adipose Tissue Insulin Resistance Index (ATIRI) is an indicator of the degree of insulin resistance in adipose tissue. Determined during a 2-hour, 7-point oral glucose tolerance test (OGTT), using fasting plasma insulin and free fatty acids (FFA) concentrations. ATIRI is calculated as: fasting FFA (mmol/L) * fasting Insulin (pmol/L. Higher ATIRI values represent lower adipose tissue insulin sensitivity.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Insulinogenic Index (IGI)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Determined during a 2-hour, 7-point oral glucose tolerance test (OGTT). The Insulinogenic Index (IGI) is a measure used to assess the early insulin response of the pancreas to a glucose load. IGI is calculated as: Plasma Insulin 0 - 30 [AUC in pmol/L x min] / Glucose 0 - 30 [AUC in mmol/L x min]. Higher IGI values represent a higher proportional secretion of insulin in response to insulin, indicative of a proportional increased pancreatic secretion of insulin.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
HOMA-β
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Determined during a 2-hour, 7-point oral glucose tolerance test (OGTT), based on fasting plasma glucose and fasting insulin levels. Homeostatic Model Assessment of Beta-cell function (HOMA-β) is a mathematical model used to estimate the function of pancreatic beta-cells, which are responsible for producing insulin. HOMA-β is calculated as: 20 × (fasting insulin (mU/L) / (fasting glucose (mmol/L) - 3.5). Normal values are ~100, higher values are indicative of increased Beta-cell activity, while lower values are indicative of decreased Beta-cell activity.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Circulating hormones such as Insulin
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Circulating hormones such as insulin are determined in plasma during a 2-hour, 7-point oral glucose tolerance test (OGTT).
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Body composition
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Body composition such as the Android/Gynoid fat mass ratio (unitless) will be determined by using a dual-energy X-ray absorptiometry scan (DXA).
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Waist circumference
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Waist circumference in centimeters.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Hip circumference
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Hip circumference in centimeters.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Waist-to-hip ratio (WHR)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Waist circumference in centimeters, divided by the hip circumference in centimeters, expressed as a unitless ratio.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Subcutaneous adipose tissue gene expression
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Subcutaneous adipose tissue biopsies will be taken for gene expression analysis. Biopsies will only be obtained in a sub-group of participants at the MUMC+, none will be obtained from participants at WUR.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Subcutaneous adipose tissue protein expression
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Subcutaneous adipose tissue biopsies will be taken for protein expression analysis. Biopsies will only be obtained in a sub-group of participants at the MUMC+, none will be obtained from participants at WUR.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Blood pressure
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Systolic and diastolic blood pressure in mmHg.
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Mean 24h glucose concentrations
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. For a 14-day period at the beginning and end of the intervention, mean 24-hour glucose levels will be monitored in all participants with a glucose sensor (FreeStyle libre 2, Research CGM, Abbot).
Measured: Change from baseline at month 12 following dietary intervention.
Glucose incremental area under the curve (iAUC)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. For a 14-day period at the beginning and end of the intervention, 24-hour glucose levels will be monitored in all participants with a glucose sensor (FreeStyle libre 2, Research CGM, Abbot). The net incremental area under the curve (iAUC) will be calculated by the trapezoid rule, using fasting glucose value as baseline. The iAUC provides a summary measure of the net increase in glucose levels above the fasting level during the 24-hour period.
Measured: Change from baseline at month 12 following dietary intervention.
The frequency of hypo- and hyperglycemia
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. For a 14-day period at the beginning and end of the intervention, 24-hour glucose levels will be monitored in all participants with a glucose sensor (FreeStyle libre 2, Research CGM, Abbot). The frequency of hypo- and hyperglycaemia will be monitored and defined as occurrences of a glucose level of ≥10.0 mmol/l for hyperglycaemia, whilst hypoglycaemia will be defined as a glucose concentration ≤ 3.9 mmol/l.
Measured: Change from baseline at month 12 following dietary intervention.
Mean Amplitude of Glucose Excursions (MAGE)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. For a 14-day period at the beginning and end of the intervention, 24-hour glucose levels will be monitored in all participants with a glucose sensor (FreeStyle Libre 2, Research CGM, Abbott).
The Mean Amplitude of Glucose Excursions (MAGE) will be calculated as the average of significant glucose fluctuations (excursions) above or below the mean glucose level. MAGE quantifies glycemic variability and is expressed in mmol/L.
Measured: Change from baseline at month 12 following dietary intervention.
Time in Range (TIR)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. For a 14-day period at the beginning and end of the intervention, 24-hour glucose levels will be monitored in all participants with a glucose sensor (FreeStyle Libre 2, Research CGM, Abbott).
The Time in Range (TIR) will be defined as the percentage of time spent within the target glucose range of 3.9-10.0 mmol/L. Time spent below 3.9 mmol/L (time below range, TBR) and above 10.0 mmol/L (time above range, TAR) will also be calculated as secondary metrics.
Measured: Change from baseline at month 12 following dietary intervention.
Coefficient of Variation (CV%)
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. For a 14-day period at the beginning and end of the intervention, 24-hour glucose levels will be monitored in all participants with a glucose sensor (FreeStyle Libre 2, Research CGM, Abbott).
The Coefficient of Variation (CV%) will be calculated as the standard deviation of glucose divided by the mean glucose level, multiplied by 100. CV% expresses glucose variability as a percentage and reflects overall glycemic stability, with a CV% > 36% considered indicative of high variability.
Measured: Change from baseline at month 12 following dietary intervention.
Standard Deviation (SD) of Glucose Levels
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. For a 14-day period at the beginning and end of the intervention, 24-hour glucose levels will be monitored in all participants with a glucose sensor (FreeStyle Libre 2, Research CGM, Abbott).
The Standard Deviation (SD) of glucose levels will be calculated as a measure of glycemic variability around the mean glucose concentration. A higher SD indicates greater glucose fluctuation and variability throughout the monitoring period.
Measured: Time Frame: Change from baseline at month 12 following dietary intervention.
The duration of hypo- and hyperglycemia
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. For a 14-day period at the beginning and end of the intervention, 24-hour glucose levels will be monitored in all participants with a glucose sensor (FreeStyle libre 2, Research CGM, Abbot). The duration of hypo- and hyperglycaemia will be monitored and defined as time spent with a glucose level of ≥10.0 mmol/l for hyperglycaemia, whilst hypoglycaemia will be defined as a glucose concentration ≤ 3.9 mmol/l.
Measured: Change from baseline at month 12 following dietary intervention.
Gut microbial composition
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Faecal samples to be used for analysing microbiota composition will be collected.
Measured: Change from baseline at month 12 following dietary intervention.
Circulating SCFA
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Circulating Short Chain Fatty Acids (SCFAs) are determined in plasma during a 2-hour, 7-point oral glucose tolerance test (OGTT).
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Targeted plasma metabolomics
At baseline, a fasting blood sample will be collected during the oral glucose tolerance test (OGTT) for determination of the Metabotypes' metabolomics profile (Nightingale).
Measured: Baseline
Circulating lipids such as FFA
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Circulating lipids such as Free Fatty Acids (FFA) are determined in serum during a 2-hour, 7-point oral glucose tolerance test (OGTT).
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Circulating inflammatory markers such as CRP
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Circulating inflammatory markers such as C-Reactive Protein (CRP) are determined in plasma during a 2-hour, 7-point oral glucose tolerance test (OGTT).
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Circulating HbA1c
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Circulating Hemoglobin A1c (HbA1c) is determined in plasma during a 2-hour, 7-point oral glucose tolerance test (OGTT).
Measured: Change from baseline at month 6 and month 12 following dietary intervention.
Physical activity
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Physical activity patterns will be monitored continuously with the ActivPAL device during a 14-day period at baseline and at the end of the intervention.
Measured: Change from baseline at month 12 following dietary intervention.
Self-reported self-efficacy
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Self-efficacy with regard to health behaviour is measured by the 13-item PAM-13 (Patient Activation Measurement questionnaire). Score ranges from 0-100, higher scores indicate a greater self-efficacy.
Measured: Change from baseline at month 6 and 12 following dietary intervention.
Self-reported context-sensitive positive health
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Positive health is measured by the 23-item Context-sensitive Positive Health Questionnaire (CPHQ), which is a newly developed questionnaire still in the validation phase. Score ranges from 0-100, higher scores indicate a greater positive health.
Measured: Change from baseline at month 1 and 12 following dietary intervention.
Self-reported mood
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Potential positive impacts on mood by the intervention are measured by the 20-item PANAS, resulting in a positive mood score (10-50; higher scores representing higher levels of positive mood), and negative mood score (10-50; lower scores representing lower levels of negative mood).
Measured: Change from baseline at month 6 and 12 following dietary intervention.
Self-reported stool consistency
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Stool consistency is measured by the Bristol Stool Chart (BSC). Score ranges from 1-7, wherein 1-2 indicates constipation, 3-4 normal stool, and 5-7 diarrhoea.
Measured: Change from baseline at month 1 and 12 following dietary intervention.
Self-reported fatigue
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Physical and mental fatigue are assessed using the 14-item Chalder fatigue scale. Scores range 0-42, wherein higher scores indicate increasing fatigue severity.
Measured: Change from baseline at month 12 following dietary intervention.
Self-reported health-related quality of life
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Health-related quality of life is measured by the 6-item EQ5-D is a short scoring tool for mobility, self-care, daily activities, pain/discomfort and fear/depression, complementary to the CPHQ. The score consists of a health index (ranging from -0.59 to 1.00, with 1 being perfect health) based on aforementioned five dimensions and a visual analog scale (VAS) from 0 to 100 to assess self-rated health.
Measured: Change from baseline at month 1 and 12 following dietary intervention.
Self-reported positive health
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Positive health is measured by the 17-item IPH-17, which is a shortened positive health questionnaire, complementary to the CPHQ. Scores range from 17-85, higher scores indicate more concerns about own health.
Measured: Change from baseline at month 1 and 12 following dietary intervention.
Adherence to dietary recommendations
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. During the 12-month intervention period, dietary compliance will be assessed before each planned visit at 1, 3, 6, 9 and 12 months. In short, roughly two weeks before each visit, participants will receive a prompt to record their food intake on two week-days and one weekend-day via Traqq App. These recording days will be automised, unannounced and non-consecutive.
Measured: 12-months, continuously throughout the study
Self-reported mental health
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Mental wellbeing is assessed using the RAND-36. Scored from 0 to 100, higher scores represent better mental health.
Measured: Change from baseline at month 6 and 12 following dietary intervention.
Self-reported perceived stress
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Perceived stress is measured with the 10-item Perceived Stress Scale (PSS10). Scores range from 0-40, higher scores represent higher levels of perceived stress.
Measured: Change from baseline at month 6 and 12 following dietary intervention.
Self-reported gastrointestinal health
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Gastrointestinal symptoms are assessed by the 15-item Gastrointestinal Symptom Rating Scale (GSRS). Scores range from 15-105, wherein higher scores indicate more severe discomfort.
Measured: Change from baseline at month 1 and 12 following dietary intervention.
Self-reported sleep quality
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Sleep quality is assessed with the 10-item Pittsburgh Sleep Quality Index. Scores range 0-21, higher scores indicate worse sleep quality.
Measured: Change from baseline at month 12 following dietary intervention.
Self-reported daytime sleepiness
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. Daytime sleepiness is assessed with the 8- item Epworth Sleepiness scale. Scores range 0-24, higher scores indicate greater daytime sleepiness.
Measured: Change from baseline at month 12 following dietary intervention.
Self-reported chronotype
Optimal (PN) versus sub-optimal (CN) diet, including within group post-hoc testing. The Munich Chronotype Questionnaire (MCTQ) assesses an individual's chronotype (biological sleep-wake preference) based on actual sleep behaviour on workdays and free days. MCTQ determines chronotype based on the midpoint of sleep on free days (MSF; hh:mm, 24-hour format)), adjusted for sleep debt (MSFsc; hh:mm, 24-hour format), and social jetlag (SJL; hh:mm, 24-hour format), where later MSFsc indicates an evening type and higher SJL reflects circadian misalignment.
Measured: Change from baseline at month 12 following dietary intervention.
DNA analysis
Buffy coats will be collected for DNA analysis, pre-intervention only, exploratory objective.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start23 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research, Health Holland, TKI Agri & Food, Nestle Health Science, Beneo GmbH, BARILLA G. e R. Fratelli S.p.A., Parma, Italy
- Responsible party
- Sponsor
- Investigators
- Ellen E Blaak, Prof. Dr. Ir., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923644
- Sponsor's protocol ID
- NL87817.068.24
- Acronym
- PRECINUT
- Status last verified
- Jan 2026
- First submitted
- 7 Feb 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the corresponding article is published and/or the project is finished, (part of) our metadata will be accessible for further research and verification. Interested researchers can submit a data request by means of a synopsis, this is necessary to prevent inappropriate use of data. A designated committee consisting of the project leader and the steering committee will decide on the approval of future requests (synopsis) for data access. At a minimum, the synopsis must show that the applicant's intended purpose and method of operation comply with the PRECINUT Data Terms of Use (see also access criteria), which have yet to be determined by the steering committee. Study participants will be provided with a participant number, which can only be connected to personal data via the informed consent form. The informed consent forms are only stored at the respective research sites separately (MUMC+/WUR), and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases
- ClinicalTrials.gov ID
- NCT06923644
- Acronym / sponsor ID
- PRECINUT / NL87817.068.24
- Keywords
- Dietary intervention trial, Precision nutrition, Tissue-specific insulin resistance, Body composition, Metabotyping, Glucose homeostasis, Cardiometabolic health, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Wageningen University and Research, Health Holland, TKI Agri & Food, Nestle Health Science, Beneo GmbH, BARILLA G. e R. Fratelli S.p.A., Parma, Italy
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nutrition is very important to keep blood sugar levels balanced. If blood sugar levels are too high, it can lead to diseases such as cardiovascular disease and type 2 diabetes (T2DM). Therefore, adjusting what one eats, also called a diet or nutritional intervention, can help prevent these diseases. However, not everyone responds the same to a diet. In about 30% of people, a diet does not work as hoped. This can be due to various reasons, such as a person's metabolism, genetic predisposition, the composition of the food one eats, or the bacteria in the intestines. Everyday things like sleep, stress, and movement also play a role. The investigators used a computer model to classify people with overweight and obesity into groups based on these factors. The investigators call such a group a 'Metabolic Phenotype', or in short 'Metabotype'. Based on the Metabotype, a personalised diet was developed (personalised nutrition intervention) that may better suit each person's unique situation.
The investigators hypothesize that a precision nutrition intervention, tailored to Metabotypes identified through unsupervised clustering (using the aforementioned computer model) of predefined, accurate features related to cardiometabolic health-specifically, tissue-specific glucose and lipid metabolism and detailed body composition-will enhance blood glucose homeostasis, reduce cardiometabolic risk, and improve adherence to the intervention and mental well-being, compared to population-based dietary guidelines. The present project will contribute to targeted and efficient precision-based dietary strategies for individuals at increased risk of T2DM.
Detailed description
Objective:
Our study aims to identify unique Metabotypes among individuals with overweight and obesity and assess their response to a 1-year precision dietary macronutrient modulation. The objective is to provide proof-of-concept that this approach improves glucose homeostasis, dietary adherence, and psychosocial well-being compared to population-based dietary guidelines.
Study design:
Two-centre dietary intervention study with a double-blind, randomised controlled parallel design, based on participants' Metabotype and hypothesized optimal diet. Participants' Metabotype and intervention arm will be blinded to the participants and researchers. Metabotypes were identified through hierarchical clustering of Principal Components (HCPC) using baseline data from The Maastricht Study (participant demographics, body composition, glucose- and insulin metabolism), whereafter clusters were cross-validated in independent cohorts. Based on a combination of post-hoc analyses of dietary intervention trials and literature, the optimal dietary macronutrient composition was determined for these Metabotypes.
Study population:
In total 240 men and women with overweight and obesity (age 40-75 years, BMI 25-40 kg/m2) will be included. Further details on in- and exclusion criteria will be described under ''Eligibility''. Following screening and baseline measurements, for each eligible participant, a classification algorithm will determine the participants' Metabotype cluster (one of three possible Metabotypes for each sex).
Intervention:
Following screening, baseline measurements, and determination of Metabotype, participants will be randomly assigned, using minimization, to either the Precision Nutrition (PN) group or the Control (CN) group. The PN group will receive a hypothesized optimal diet for their specific Metabotype, while the control group will be randomly assigned one of the diets optimized for a different Metabotype of the same sex. All participants will follow their assigned diets for 12 months, with each diet conforming to the Dutch healthy dietary guidelines. Participants will receive regular dietary consultation, and meal plans including variation lists to guide them with their dietary intake during the intervention.
Main study parameters/endpoints:
Extensive characterization will be done before, during, and after the intervention. Primary outcome measure is whole-body insulin sensitivity (Matsuda index) assessed by means of a 7-point oral glucose tolerance test (OGTT). Secondary outcomes include glycaemic variability, mean glucose levels, fasting lipid profiles, body composition, blood pressure, gene and protein expression of adipose tissue, microbial composition and functionality, metabolomics, physical activity, adherence to dietary recommendations, (mental) well-being, and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision Nutrition Group (PN) | Experimental | Other: Optimal Metabotype-specific dietFor a total duration of 12 months, participants in the Precision Nutrition (PN) Group will follow a diet tailored to their Metabotype, which is hypothesised to be optimal for them. |
| Control Group (CN) | Experimental | Other: Sub-optimal dietFor a total duration of 12 months, participants in the Control Group (CN) will be randomly assigned one of the diets optimised for a different Metabotype of the same sex, which is hypothesised to be suboptimal for them. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women with a BMI ≥25 to <40 kg/m2
- Classification possible to one of the investigational metabolic phenotypes according to the classification algorithm.
- Weight stability for at least 3 months (+/- 3 kg)
Key exclusion criteria (38 listed)
- Diseases
- (Pre-)diagnosis of type 1 or type 2 diabetes mellitus (i.e., FPG ≥ 7,0 mmol/L) and HbA1c ≥ 6,5% (48 mmol/mol)
- Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT and creatinine values)
- Gastrointestinal diseases or abdominal surgery (allowed i.e.:
- appendectomy, cholecystectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal Metabotype-specific dietFollowing screening, baseline measurements, and determination of Metabotype, participants will be randomly assigned, using minimisation, to either the Precision Nutrition (PN) group or the Control (CN) group. The PN group will receive a diet hypothesised to be optimal for their specific Metabotype. All participants will adhere to their assigned diets for 12 months. Each Metabotype-specific diet will align with the Dutch Healthy Dietary Guidelines, while varying in macronutrient composition and quality. | Other | Precision Nutrition Group (PN) |
| Sub-optimal dietParticipants randomised to the Control Group (CN), will be randomly assigned one of the two diets optimised for a different Metabotype of the same sex. The assigned CN Group diet will always have a macronutrient content and quality that is different than their hypothesised optimal diet. All diets will align with the Dutch Healthy Dietary Guidelines. | Other | Control Group (CN) |
Primary outcome
Matsuda Index
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
The primary objective of this study is to evaluate the effect of a 12-month Metabotype-targeted diet (PN) versus a non-targeted diet (CN) on whole-body insulin sensitivity (Matsuda Index; marker of whole-body fasting and postprandial insulin sensitivity). This will include within group post-hoc testing. The primary outcome measure will be assessed by means of a 7-point oral glucose tolerance test (OGTT), and calculated as follows: [10,000 / square root of [fasting plasma glucose (mg/dL) × fasting insulin (mU/L)] × [mean glucose (mg/dL) x mean insulin (mU/L)]].
46 secondary outcomes
Glucose tolerance
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Disposition Index (DI)
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
HOMA-IR
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Muscle insulin sensitivity (MISI)
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Hepatic insulin resistance (HIRI)
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Adipose tissue insulin sensitivity (ATIRI)
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Insulinogenic Index (IGI)
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
HOMA-β
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Circulating hormones such as Insulin
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Body composition
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Waist circumference
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Hip circumference
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Waist-to-hip ratio (WHR)
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Subcutaneous adipose tissue gene expression
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Subcutaneous adipose tissue protein expression
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Blood pressure
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Mean 24h glucose concentrations
Time frame: Change from baseline at month 12 following dietary intervention.
Glucose incremental area under the curve (iAUC)
Time frame: Change from baseline at month 12 following dietary intervention.
The frequency of hypo- and hyperglycemia
Time frame: Change from baseline at month 12 following dietary intervention.
Mean Amplitude of Glucose Excursions (MAGE)
Time frame: Change from baseline at month 12 following dietary intervention.
Time in Range (TIR)
Time frame: Change from baseline at month 12 following dietary intervention.
Coefficient of Variation (CV%)
Time frame: Change from baseline at month 12 following dietary intervention.
Standard Deviation (SD) of Glucose Levels
Time frame: Time Frame: Change from baseline at month 12 following dietary intervention.
The duration of hypo- and hyperglycemia
Time frame: Change from baseline at month 12 following dietary intervention.
Gut microbial composition
Time frame: Change from baseline at month 12 following dietary intervention.
Circulating SCFA
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Targeted plasma metabolomics
Time frame: Baseline
Circulating lipids such as FFA
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Circulating inflammatory markers such as CRP
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Circulating HbA1c
Time frame: Change from baseline at month 6 and month 12 following dietary intervention.
Physical activity
Time frame: Change from baseline at month 12 following dietary intervention.
Self-reported self-efficacy
Time frame: Change from baseline at month 6 and 12 following dietary intervention.
Self-reported context-sensitive positive health
Time frame: Change from baseline at month 1 and 12 following dietary intervention.
Self-reported mood
Time frame: Change from baseline at month 6 and 12 following dietary intervention.
Self-reported stool consistency
Time frame: Change from baseline at month 1 and 12 following dietary intervention.
Self-reported fatigue
Time frame: Change from baseline at month 12 following dietary intervention.
Self-reported health-related quality of life
Time frame: Change from baseline at month 1 and 12 following dietary intervention.
Self-reported positive health
Time frame: Change from baseline at month 1 and 12 following dietary intervention.
Adherence to dietary recommendations
Time frame: 12-months, continuously throughout the study
Self-reported mental health
Time frame: Change from baseline at month 6 and 12 following dietary intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Yes. Once the corresponding article is published and/or the project is finished, (part of) our metadata will be accessible for further research and verification. Interested researchers can submit a data request by means of a synopsis, this is necessary to prevent inappropriate use of data. A designated committee consisting of the project leader and the steering committee will decide on the approval of future requests (synopsis) for data access. At a minimum, the synopsis must show that the applicant's intended purpose and method of operation comply with the PRECINUT Data Terms of Use (see also access criteria), which have yet to be determined by the steering committee. Study participants will be provided with a participant number, which can only be connected to personal data via the informed consent form. The informed consent forms are only stored at the respective research sites separately (MUMC+/WUR), and will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen E Blaak, Prof. Dr. Ir. principal investigator
Maastricht University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal Metabotype-specific diet and Sub-optimal diet in people with Obesity and Overweight and Pre-diabetic, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen E Blaak, Prof. Dr. Ir. (+31433881503, e.blaak@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matsuda Index (time frame: Change from baseline at month 6 and month 12 following dietary intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.