Personalized NutritionNCT05402085
N=1 Trials of Individual Variability in Post-prandial Glycemic Responses to Diets of Varying Macronutrient Composition
A study testing High Protein Diet, High Fat Diet and High Carbohydrate-Low Glycemic Index Diet in people with Personalized Nutrition, run by National University of Singapore at 1 site in Singapore.
Trial summary
The key objective of this study is to identify the most suitable diet (i.e. high protein, high fat, low GI, high GI) for an individual. Importantly, we further seek to identify the biological determinants of inter-individual variability and to understand how these determinants affect blood glucose. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Personalized Nutrition
- What is being tested?
- High Protein Diet, High Fat Diet and High Carbohydrate-Low Glycemic Index Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Sep 2020to 31 Dec 2024
- 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 21 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to give informed consent
- 21 to 60 years of age (inclusive) at screening
- Race must be Chinese or Indian or Malay
- Overtly healthy males, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Males with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
- Not on any regular medications (western / traditional medicine)
- Nutritional supplements with established chemical composition that can be ascertained and clearly recorded is acceptable. Participants have to stop taking nutritional supplements at least 2 weeks before the start of study period.
- Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Who cannot join
- Female
- A current smoker, or has smoked in the past 2 years
- History or presence of current lipid and cardiovascular disorders, respiratory, hepatic, renal, gastrointestinal, endocrine, lipid disorder, haematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data
- History of food allergies to test foods
- Regular use of medication that may affect glucose metabolism (e.g. steroids)
- History of type 1/type 2 diabetes and use of anti-diabetic medications in the past
Show all 26Show fewer
- History of regular use of aspirin or vitamin C (both can affect glucose readings on CGM)
- Regularly use known drugs or abuse within 3 years
- Known or ongoing psychiatric disorders within 3 years
- Have donated blood of more than 500 mL within 4 weeks of study enrolment
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females):
- 1 unit = 12 oz or 360 mL of beer;
- 5 oz or 150 mL of wine;
- 1.5 oz or 45 mL of distilled spirits
- Uncontrolled hypertension (blood pressure [BP] >160/100mmHg)
- Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
- Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study
- Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study
- History of bleeding diathesis or coagulopathy
- Any of the following laboratory values at screening:
- Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)
- Clinically significant (as determined by investigator) abnormalities on laboratory examination that will increase risk to the patient or interfere with data integrity
- Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
- Significant change in weight (+/- 5%) during the past month
- Any hospitalization or surgery during the 6 months before enrolment in study
- Participants with antibiotic use in past 2 months
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University of Singapore
Singapore, Singapore, 118177
About this study
Official title: Physiological, Biochemical and Gut Microbial Determinants of Individual Variability in Post-prandial Glycemic Response to Diets of Varying Macronutrient Composition- Towards Personalized Nutrition Through Aggregated N=1 Trials
The key objective of this study is to identify the most suitable diet (i.e. high protein, high fat, low GI, high GI) for an individual. Importantly, we further seek to identify the biological determinants of inter-individual variability and to understand how these determinants affect blood glucose. The deep metabolic phenotyping, multi-omics profiling of each subject and fine-mapping of their glycemic responses to different diets will allow us to obtain preliminary data on the mechanistic basis underlying inter-individual dietary glycemic response. Data from this study will form the basis of large clinical trials, the development of novel foods, and/or novel technologies to alter the gut micro-biome for optimal blood glucose control.
Read the detailed description
Diet plays a large role in determining our blood glucose levels, which in turn, can affect our risk of diabetes mellitus and heart disease. Traditionally, dietary recommendations are made for populations or groups of people. There is increasing recognition that each of us is an individual, with our own genetic background, physiology, and lifestyle. Each of these affects the way we digest and use the nutrients in foods that we consume. Recent studies have shown that different individuals consuming the same meal have very different glycaemic responses. The optimal diet for one person may not be the optimal diet for another. This could explain the controversies around our attempts to define the best diet for the population - there simply isn't one diet that is optimal for everybody. In our study, we will utilize an n-of-1 study design where each person receives all 3 diets one after another in a random sequence. We will measure blood glucose using a device that measures the interstitial blood glucose every 15 minutes for 2 weeks. The glycaemic effects of each diet will then be compared with the control diet in the same individual such that each person serves as his/her own control. The response is thus individualized.
- Conditions
- Personalized Nutrition
- Being tested
- High Protein Diet, High Fat Diet, High Carbohydrate-Low Glycemic Index Diet, High Carbohydrate-High Glycemic Index Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein DietDietary supplement
Subjects will be provided with high protein diet meals for breakfast, lunch, and dinner. A continuous glucose monitoring device will be used to measure post-prandial glycemic responses.
High Fat DietDietary supplement
Subjects will be provided with high fat diet meals for breakfast, lunch, and dinner. A continuous glucose monitoring device will be used to measure post-prandial glycemic responses.
High Carbohydrate-Low Glycemic Index DietDietary supplement
Subjects will be provided with high carbohydrate-low glycemic index diet meals for breakfast, lunch, and dinner. A continuous glucose monitoring device will be used to measure post-prandial glycemic responses.
High Carbohydrate-High Glycemic Index DietDietary supplement
Subjects will be provided with high carbohydrate-high glycemic index diet meals for breakfast, lunch, and dinner. A continuous glucose monitoring device will be used to measure post-prandial glycemic responses.
| Study group | Role | What they receive |
|---|---|---|
| High Protein Diet | Experimental | Diet consisting of 40% carbohydrate, 40% protein, 20% fat, with Glycemic Index ~55-65. Receives: Dietary Supplement: High Protein Diet |
| High Fat Diet | Experimental | Diet consisting of 40% carbohydrate, 40% fat (25% monounsaturated fatty acids), 20% protein, with Glycemic Index ~55-65. Receives: Dietary Supplement: High Fat Diet |
| High Carbohydrate-Low Glycemic Index Diet | Experimental | Diet consisting of 60% carbohydrate, 20% fat, 20% protein, with Glycemic Index ~45-50. Receives: Dietary Supplement: High Carbohydrate-Low Glycemic Index Diet |
| High Carbohydrate-High Glycemic Index Diet | Placebo comparator | Diet consisting of 60% carbohydrate, 20% fat, 20% protein. Receives: Dietary Supplement: High Carbohydrate-High Glycemic Index Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-individual differences in glycemic response to various meal types.
To quantify inter-individual differences in glycemic response to high carbohydrate-high glycemic index, high carbohydrate-low glycemic index, high-protein and high-fat diets using continuous glucose monitoring.
Measured: 14 days
Secondary outcomes (4)
Correlation of metagenomic profile to inter-individual glycemic response differences from various meal types.
Correlation of metagenomic profile from shotgun sequencing of DNA to differences in inter-individual glycemic response of individuals from various meal types (primary outcome).
Measured: 14 days
Correlation of metabolome profile to inter-individual glycemic response differences from various meal types.
Correlation of metabolome profile from blood samples to differences in inter-individual glycemic response of individuals from various meal types (primary outcome).
Measured: 14 days
Correlation of sleep score quality to different glycemic responses from various meal types.
Correlation of sleep score quality derived from Fitbit active watch to different glycemic responses from various meal types (primary outcome).
Measured: 14 days
Correlation of number of step counts from physical activity to different glycemic responses from various meal types.
Correlation of number of step counts from physical activity derived from Fitbit active watch to different glycemic responses from various meal types (primary outcome).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start3 Sep 2020
- Primary completion11 Oct 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personalized NutritionStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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
- Crossover
- Model description
- A 120 single-subject trials (n-of-1 trials) is proposed to compare the glycaemic response of three common diets, i.e. a high carbohydrate-low glycemic index diet, a high protein diet, and a high fat diet. An n-of-1 trial is a clinical trial in which a single individual is the entire trial. Each individual serves as his/her own control, and different intervention are administered in a cross-over design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Hui Liu, National University of Singapore
- Investigators
- Mei Hui Liu, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402085
- Sponsor's protocol ID
- 2019/00638
- Other IDs
- 2019
- Status last verified
- Nov 2024
- First submitted
- 23 May 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological, Biochemical and Gut Microbial Determinants of Individual Variability in Post-prandial Glycemic Response to Diets of Varying Macronutrient Composition- Towards Personalized Nutrition Through Aggregated N=1 Trials
- ClinicalTrials.gov ID
- NCT05402085
- Acronym / sponsor ID
- 2019/00638
- Conditions
- Personalized Nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Jun 2022 (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 key objective of this study is to identify the most suitable diet (i.e. high protein, high fat, low GI, high GI) for an individual. Importantly, we further seek to identify the biological determinants of inter-individual variability and to understand how these determinants affect blood glucose. The deep metabolic phenotyping, multi-omics profiling of each subject and fine-mapping of their glycemic responses to different diets will allow us to obtain preliminary data on the mechanistic basis underlying inter-individual dietary glycemic response. Data from this study will form the basis of large clinical trials, the development of novel foods, and/or novel technologies to alter the gut micro-biome for optimal blood glucose control.
Detailed description
Diet plays a large role in determining our blood glucose levels, which in turn, can affect our risk of diabetes mellitus and heart disease. Traditionally, dietary recommendations are made for populations or groups of people. There is increasing recognition that each of us is an individual, with our own genetic background, physiology, and lifestyle. Each of these affects the way we digest and use the nutrients in foods that we consume. Recent studies have shown that different individuals consuming the same meal have very different glycaemic responses. The optimal diet for one person may not be the optimal diet for another. This could explain the controversies around our attempts to define the best diet for the population - there simply isn't one diet that is optimal for everybody. In our study, we will utilize an n-of-1 study design where each person receives all 3 diets one after another in a random sequence. We will measure blood glucose using a device that measures the interstitial blood glucose every 15 minutes for 2 weeks. The glycaemic effects of each diet will then be compared with the control diet in the same individual such that each person serves as his/her own control. The response is thus individualized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- A 120 single-subject trials (n-of-1 trials) is proposed to compare the glycaemic response of three common diets, i.e. a high carbohydrate-low glycemic index diet, a high protein diet, and a high fat diet. An n-of-1 trial is a clinical trial in which a single individual is the entire trial. Each individual serves as his/her own control, and different intervention are administered in a cross-over design.
| Arm | Type | Receives |
|---|---|---|
| High Protein Diet | Experimental | Dietary Supplement: High Protein DietDiet consisting of 40% carbohydrate, 40% protein, 20% fat, with Glycemic Index ~55-65. |
| High Fat Diet | Experimental | Dietary Supplement: High Fat DietDiet consisting of 40% carbohydrate, 40% fat (25% monounsaturated fatty acids), 20% protein, with Glycemic Index ~55-65. |
| High Carbohydrate-Low Glycemic Index Diet | Experimental | Dietary Supplement: High Carbohydrate-Low Glycemic Index DietDiet consisting of 60% carbohydrate, 20% fat, 20% protein, with Glycemic Index ~45-50. |
| High Carbohydrate-High Glycemic Index Diet | Placebo comparator | Dietary Supplement: High Carbohydrate-High Glycemic Index DietDiet consisting of 60% carbohydrate, 20% fat, 20% protein. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ability to give informed consent
- 21 to 60 years of age (inclusive) at screening
- Race must be Chinese or Indian or Malay
- Overtly healthy males, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Males with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
Key exclusion criteria (26 listed)
- Female
- A current smoker, or has smoked in the past 2 years
- History or presence of current lipid and cardiovascular disorders, respiratory, hepatic, renal, gastrointestinal, endocrine, lipid disorder, haematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data
- History of food allergies to test foods
- Regular use of medication that may affect glucose metabolism (e.g. steroids)
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 |
|---|---|---|
| High Protein DietSubjects will be provided with high protein diet meals for breakfast, lunch, and dinner. A continuous glucose monitoring device will be used to measure post-prandial glycemic responses. | Dietary supplement | High Protein Diet |
| High Fat DietSubjects will be provided with high fat diet meals for breakfast, lunch, and dinner. A continuous glucose monitoring device will be used to measure post-prandial glycemic responses. | Dietary supplement | High Fat Diet |
| High Carbohydrate-Low Glycemic Index DietSubjects will be provided with high carbohydrate-low glycemic index diet meals for breakfast, lunch, and dinner. A continuous glucose monitoring device will be used to measure post-prandial glycemic responses. | Dietary supplement | High Carbohydrate-Low Glycemic Index Diet |
| High Carbohydrate-High Glycemic Index DietSubjects will be provided with high carbohydrate-high glycemic index diet meals for breakfast, lunch, and dinner. A continuous glucose monitoring device will be used to measure post-prandial glycemic responses. | Dietary supplement | High Carbohydrate-High Glycemic Index Diet |
Primary outcome
Inter-individual differences in glycemic response to various meal types.
Time frame: 14 days
To quantify inter-individual differences in glycemic response to high carbohydrate-high glycemic index, high carbohydrate-low glycemic index, high-protein and high-fat diets using continuous glucose monitoring.
4 secondary outcomes
Correlation of metagenomic profile to inter-individual glycemic response differences from various meal types.
Time frame: 14 days
Correlation of metabolome profile to inter-individual glycemic response differences from various meal types.
Time frame: 14 days
Correlation of sleep score quality to different glycemic responses from various meal types.
Time frame: 14 days
Correlation of number of step counts from physical activity to different glycemic responses from various meal types.
Time frame: 14 days
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 15 Nov 2024.
- 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.
Mei Hui Liu principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Diet, High Fat Diet and High Carbohydrate-Low Glycemic Index Diet in people with Personalized Nutrition, run by National University of Singapore at 1 site in Singapore.
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 8 inclusion and 26 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 15 Nov 2024. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Inter-individual differences in glycemic response to various meal types. (time frame: 14 days). 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 15 Nov 2024.