N=1 Trials of Individual Variability in Post-prandial Glycemic Responses to Diets of Varying Macronutrient Composition

NCT05402085 | Active Not Recruiting DMC

• 1 other identifier: 2019/00638
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Personalized Nutrition

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (4)

• Correlation of metagenomic profile to inter-individual glycemic response differences from various meal types.

  14 days

• Correlation of metabolome profile to inter-individual glycemic response differences from various meal types.

  14 days

• Correlation of sleep score quality to different glycemic responses from various meal types.

  14 days

• Correlation of number of step counts from physical activity to different glycemic responses from various meal types.

  14 days

Study Arms (4)

High Protein Diet

EXPERIMENTAL

Diet consisting of 40% carbohydrate, 40% protein, 20% fat, with Glycemic Index \~55-65.

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.

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.

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.

Dietary Supplement: High Carbohydrate-High Glycemic Index Diet

Interventions

High Protein Diet DIETARY_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 Protein Diet

High Fat Diet DIETARY_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 Fat Diet

High Carbohydrate-Low Glycemic Index Diet DIETARY_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-Low Glycemic Index Diet

High Carbohydrate-High Glycemic Index Diet DIETARY_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.

High Carbohydrate-High Glycemic Index Diet

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to give informed consent
• 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.

You may not qualify if:

• 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
• 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):
• unit = 12 oz or 360 mL of beer;
• oz or 150 mL of wine;
• oz or 45 mL of distilled spirits
• Uncontrolled hypertension (blood pressure \[BP\] \>160/100mmHg)

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, Singapore, 118177, Singapore

Location

MeSH Terms

Interventions

Diet, High-Protein; Diet, High-Fat

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mei Hui Liu

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded as to which diet they are receiving for each day of the 14-day study.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: September 3, 2020
• Primary Completion: October 11, 2022
• Study Completion: December 31, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)