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Westlake N-of-1 Trials for Macronutrient Intake 2 ( WE-MACNUTR 2)

NCT05161182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-06-01

No results posted yet for this study

Summary

Diet and nutrition are key to maintain human health. Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR) trial investigates individualized postprandial glycemic responses to different proportions of dietary fat and carbohydrates intake using an n-of-1 experimental study design. The experimental diets are isocaloric high fat, low carbohydrate (HF-LC) or low fat, high carbohydrate (LF-HC). With standardized intervention and strictly controlled eating behaviors, the WE-MACNUTR study identifies specific HC-responders and HF-responders in terms of postprandial glucose response.

This is a follow-up study offered to participants who have completed the WE-MACNUTR study in 2019. Volunteers will be asked to participate in four 5-d periods while wearing glucose monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be randomly assigned. Participants will be asked to provide a fasted blood sample and to collect fecal, urine and saliva samples at each visits.

Conditions

  • Postprandial Hyperglycemia
  • Metabolic Disorder, Glucose

Interventions

OTHER

High fat, low carbohydrate diet

Throughout the 5-day intervention, participants are provided with a high fat, low carbohydrate (HF-LC) diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25%, respectively.

OTHER

Low fat, high carbohydrate diet

Throughout the 5-day intervention, participants are provided with a low fat, high carbohydrate (LF-HC) diet in which the percentage of fat, protein and carbohydrate is 10%, 15% and 75%, respectively.

Sponsors & Collaborators

  • Westlake University

    lead OTHER

Principal Investigators

  • Ju-Sheng Zheng, PhD · Westlake University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-30
Primary Completion
2021-11-18
Completion
2021-11-19

Countries

  • China

Study Locations

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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 NCT05161182 on ClinicalTrials.gov