Westlake N-of-1 Trials for Macronutrient Intake — WE-MACNUTR  

Postprandial Hyperglycemia Clinical Trial

Official title: Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake

Status Completed

Clinical Trial Summary

This is a dietary intervention study in students and staff of Westlake University, which is designed to provide evidence in support of N-of-1 methods as an approach to advance personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group level.

Clinical Trial Description

This study will employ a series of individual N-of-1 trials comparing a high fat, low carbohydrate diet (HF-LC) to a low fat, high carbohydrate diet (LF-HC). Participants will enter the study on a usual diet and will have a 6-day run in period for diet planning and baseline data collection before beginning their intervention. The HF-LC or the LF-HC will be randomized as the starting intervention followed by a wash-out period lasting for 6 days with normal diet between two interventions to eliminate previous intervention effects. Then the participants will be provided with the other diet. Both HF-LC and LF-HC last for 6 days in each set which consists of two wash-out periods and two intervention periods. There will be 3 sets in this study and investigators will aggregate the results of the completed N-of-1 trials across all participants to estimate the group level impacts of HF-LC compared to LF-HC. ;

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Hyperglycemia
• Metabolic Diseases
• Metabolic Disorder, Glucose
• Postprandial Hyperglycemia

• NCT number: NCT04125602
• Study type: Interventional
• Source: Westlake University
• Status: Completed
• Phase: N/A
• Start date: October 20, 2019
• Completion date: December 31, 2019