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

Westlake University

Status

Completed

Conditions

Postprandial Hyperglycemia

Metabolic Disorder, Glucose

Treatments

Other: High fat low carbohydrate diet

Other: Low fat high carbohydrate diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04125602

20190919ZJS001

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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