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

NCT05402085 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-11-15

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

High Protein Diet

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.

DIETARY_SUPPLEMENT

High Fat Diet

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.

DIETARY_SUPPLEMENT

High Carbohydrate-Low Glycemic Index Diet

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.

DIETARY_SUPPLEMENT

High Carbohydrate-High Glycemic Index Diet

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.

Sponsors & Collaborators

Principal Investigators

  • Mei Hui Liu · National University of Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2022-10-11
Completion
2024-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05402085 on ClinicalTrials.gov