Westlake N-of-1 Trials for Macronutrient Intake

Not Applicable

Completed

• Conditions: Metabolic Disorder, Glucose; Postprandial Hyperglycemia
• Interventions: Other: High fat low carbohydrate diet; Other: Low fat high carbohydrate diet

• Registration Number: NCT04125602
• Lead Sponsor: Westlake University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Study Start: 2019-10-20
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Willingness and capability to complete the study protocol

Exclusion Criteria

• Inability or unwillingness to approved to provide informed consent
• Neurological conditions that might affect the assessment of the study measurement
• Hospitalization or surgery planned within 3 months
• Gastrointestinal diseases
• Other serious medical conditions, such as liver, kidney, or systemic disease
• Women who are pregnant or lactating
• Tobacco, alcohol, or illicit drug abuse
• Had taken antibiotics in the past two weeks prior to the start of the trial
• Participants on a vegan diet
• Any food allergy
• Lack of smart phone and data plan for participating caregiver
• Non-Chinese speaking participants
• Participating in another concurrent intervention study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High fat low carbohydrate diet	Low fat high carbohydrate diet	-
Low fat high carbohydrate diet	High fat low carbohydrate diet	-
Low fat high carbohydrate diet	Low fat high carbohydrate diet	-
High fat low carbohydrate diet	High fat low carbohydrate diet	-

Primary Outcome Measures

Name	Time	Method
Blood glucose profiling	Day 7-12 and day 19-24 of each set	Glucose levels will be recorded by continuous glucose monitoring over the intervention periods.
Postprandial blood glucose change	Day 7-12 and day 19-24 of each set	Postprandial blood glucose from different foods will be assessed.

Trial Locations

Locations (1)

Westlake University; 🇨🇳 Hangzhou, Zhejiang, China