OverweightPROTIMENCT06382480
PROTeIn-rich Meals to Control Glucose
A study testing Diet with specific macronutrient composition. in people with Overweight and Obesity, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight, Obesity, Prediabetes
- What is being tested?
- Diet with specific macronutrient composition.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 12 Apr 2024to 28 Feb 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prediabetes (fasting blood sugar 100-125 mg/dl)
- Diabetes type 2 (fasting blood sugar \>126 mg/dl)
- Overweight and obesity (BMI 25-50 kg/m2)
Who cannot join
- Other diabetes types
- Insulin treatment
- Shift work
- Weight changes \>5% within past 3 months
- Systemic glucocorticoid therapy
- Systemic infections
Show all 19Show fewer
- Severe anemia
- High blood pressure (\>180/110 mmHg)
- Endocrinologic, liver and heart disorders
- Immune diseases
- Thyroid dysfunction
- Heart attack or stroke
- Cancer in the last 2 years
- Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases
- Hereditary or acquired coagulation disorders
- Non-interruptible intake of blood thinners (anticoagulants)
- Specific diets, intermittent fasting
- Pregnancy or breastfeeding
- Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes
The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.
Read the detailed description
Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat.
- Conditions
- Overweight, Obesity, Prediabetes, Type 2 Diabetes
- Being tested
- Diet with specific macronutrient composition.
- Keywords
- Glucose, Overweight, Obesity, Prediabetes, Type 2 Diabetes, Metabolism, Chrononutrition, Macronutrient composition, High-protein, High-carb, Isocaloric diet, Prevention and treatment of type 2 diabetes
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet with specific macronutrient composition.Other
The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10%E protein, 60%E carbs, and 30%E fat.
| Study group | Role | What they receive |
|---|---|---|
| HP/HC - HC/HP | Experimental | Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention. Receives: Other: Diet with specific macronutrient composition. |
| HC/HP - HP/HC | Experimental | Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention. Receives: Other: Diet with specific macronutrient composition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour glucose
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
Measured: 4 weeks
Secondary outcomes (19)
Measurement of height
Height measured by stadiometer
Measured: 4 weeks
Measurement of body weight
Body weight measured by body scale
Measured: 4 weeks
Waist and hip circumference / waist to hip ratio
Waist and hip circumference measured by tape measure
Measured: 4 weeks
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure changes measurement by manometer
Measured: 4 weeks
Body fat and lean mass
Body fat and lean mass assessed by bioelectrical impendance analysis (BIA)
Measured: 4 weeks
Energy expenditure and substrate oxidation rates
Energy expenditure and substrate oxidation rates assessed by indirect calorimetry
Measured: 4 weeks
Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))
GGT, AST, ALT etermined in fasting blood samples
Measured: 4 weeks
Renal values (creatinine, urea, uric acid)
Renal values determined in fasting blood samples
Measured: 4 weeks
Intra- und inter-day glycemic variability
Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM)
Measured: 4 weeks
Glucose levels in meal tolerance test (MTT)
Glucose levels in blood samples collected in MTT
Measured: 4 weeks
Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)
Blood levels of metabolic hormones assessed in fasting state and during the MTT
Measured: 4 weeks
Inflammatory markers and T cell populations analyses
Level of the inflammatory markers IL-6, TNFa, MCP-1 and T cell populations in circulation and adipose tissue are assessed through blood analysis and fat biopsy
Measured: 4 weeks
Satiety and hunger scores
Satiety and hunger scores assessed using Visual Analog Scale (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)
Measured: 4 weeks
Sleep/wake timing and sleep quality
Sleep/wake timing and sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and also monitored by an ActiGraph device
Measured: 4 weeks
Physical activity
24-h physical activity will be monitored by an ActiGraph device
Measured: 4 weeks
Adipose tissue transcriptome
RNA-Seq analysis of subcutaneous adipose tissue sample
Measured: 4 weeks
Gene expression in peripheral blood mononuclear cells (PBMC)
Expression of metabolic genes assessed by qPCR
Measured: 4 weeks
Gut microbiota and microbiome-derived metabolites
Determined in stool samples and blood plasma
Measured: 4 weeks
Determination of decision behavior
Impulsiveness assessed by decision making tasks on computer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start12 Apr 2024
- Primary completion21 Apr 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake divided by a 4-week wash-out phase.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Helmholtz Zentrum München, Hasso Plattner Institute, Potsdam, Germany
- Responsible party
- Principal investigator, Olga Ramich (formerly Pivovarova), German Institute of Human Nutrition
- Investigators
- Olga Ramich, PD Dr., Principal investigator, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382480
- Sponsor's protocol ID
- 90/2023
- Acronym
- PROTIME
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06382480
- Acronym / sponsor ID
- PROTIME / 90/2023
- Conditions
- Overweight, Obesity, Prediabetes, Type 2 Diabetes
- Keywords
- Glucose, Overweight, Obesity, Prediabetes, Type 2 Diabetes, Metabolism, Chrononutrition, Macronutrient composition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Helmholtz Zentrum München, Hasso Plattner Institute, Potsdam, Germany
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Apr 2024 (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.
The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.
Detailed description
Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake divided by a 4-week wash-out phase.
| Arm | Type | Receives |
|---|---|---|
| HP/HC - HC/HP | Experimental | Other: Diet with specific macronutrient composition.Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention. |
| HC/HP - HP/HC | Experimental | Other: Diet with specific macronutrient composition.Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prediabetes (fasting blood sugar 100-125 mg/dl)
- Diabetes type 2 (fasting blood sugar \>126 mg/dl)
- Overweight and obesity (BMI 25-50 kg/m2)
Key exclusion criteria (19 listed)
- Other diabetes types
- Insulin treatment
- Shift work
- Weight changes \>5% within past 3 months
- Systemic glucocorticoid therapy
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 |
|---|---|---|
| Diet with specific macronutrient composition.The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10%E protein, 60%E carbs, and 30%E fat. | Other | HC/HP - HP/HC, HP/HC - HC/HP |
Primary outcome
Mean 24-hour glucose
Time frame: 4 weeks
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
19 secondary outcomes
Measurement of height
Time frame: 4 weeks
Measurement of body weight
Time frame: 4 weeks
Waist and hip circumference / waist to hip ratio
Time frame: 4 weeks
Systolic and diastolic blood pressure
Time frame: 4 weeks
Body fat and lean mass
Time frame: 4 weeks
Energy expenditure and substrate oxidation rates
Time frame: 4 weeks
Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))
Time frame: 4 weeks
Renal values (creatinine, urea, uric acid)
Time frame: 4 weeks
Intra- und inter-day glycemic variability
Time frame: 4 weeks
Glucose levels in meal tolerance test (MTT)
Time frame: 4 weeks
Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)
Time frame: 4 weeks
Inflammatory markers and T cell populations analyses
Time frame: 4 weeks
Satiety and hunger scores
Time frame: 4 weeks
Sleep/wake timing and sleep quality
Time frame: 4 weeks
Physical activity
Time frame: 4 weeks
Adipose tissue transcriptome
Time frame: 4 weeks
Gene expression in peripheral blood mononuclear cells (PBMC)
Time frame: 4 weeks
Gut microbiota and microbiome-derived metabolites
Time frame: 4 weeks
Determination of decision behavior
Time frame: 4 weeks
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Olga Ramich, PD Dr. principal investigator
German Institute of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet with specific macronutrient composition. in people with Overweight and Obesity, run by German Institute of Human Nutrition at 1 site in Germany.
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 19 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 24-hour glucose (time frame: 4 weeks). 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 29 Sep 2026.