Active — Not RecruitingNot Applicable

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

Singapore120 participantsStarted 2020-09-03

Plain-language 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.

Who can participate

Age range21 Years – 60 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 …

What they're measuring

Inter-individual differences in glycemic response to various meal types.

Timeframe: 14 days

Trial details

NCT IDNCT05402085

SponsorNational University of Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-11