Westlake N-of-1 Trials for Macronutrient Intake

NCT ID: NCT04125602

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-20
• Study Completion Date: 2019-12-31

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.

Conditions

Postprandial Hyperglycemia; Metabolic Disorder, Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

High fat low carbohydrate diet

Group Type: EXPERIMENTAL

High fat low carbohydrate diet

Intervention Type: OTHER

Throughout the 6-day intervention, participants are provided with a high fat, low carbohydrate diet (HF-LCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25% respectively while the three macronutrients in the other 3-day diet account for 70%, 15% and 15% respectively. The sequencing of the two diets will be randomized.

Low fat high carbohydrate diet

Intervention Type: OTHER

Throughout the 6-day intervention, participants are provided with a low fat, high carbohydrate diet (LF-HCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 20%, 15% and 65% respectively while the three macronutrients in the other 3-day diet account for 10%, 15% and 75% respectively. The sequencing of the two diets will be randomized.

Low fat high carbohydrate diet

Group Type: EXPERIMENTAL

High fat low carbohydrate diet

Intervention Type: OTHER

Throughout the 6-day intervention, participants are provided with a high fat, low carbohydrate diet (HF-LCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25% respectively while the three macronutrients in the other 3-day diet account for 70%, 15% and 15% respectively. The sequencing of the two diets will be randomized.

Low fat high carbohydrate diet

Intervention Type: OTHER

Throughout the 6-day intervention, participants are provided with a low fat, high carbohydrate diet (LF-HCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 20%, 15% and 65% respectively while the three macronutrients in the other 3-day diet account for 10%, 15% and 75% respectively. The sequencing of the two diets will be randomized.

Interventions

High fat low carbohydrate diet

Throughout the 6-day intervention, participants are provided with a high fat, low carbohydrate diet (HF-LCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25% respectively while the three macronutrients in the other 3-day diet account for 70%, 15% and 15% respectively. The sequencing of the two diets will be randomized.

Intervention Type: OTHER

Low fat high carbohydrate diet

Throughout the 6-day intervention, participants are provided with a low fat, high carbohydrate diet (LF-HCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 20%, 15% and 65% respectively while the three macronutrients in the other 3-day diet account for 10%, 15% and 75% respectively. The sequencing of the two diets will be randomized.

Intervention Type: OTHER

Other Intervention Names

HF-LCD; LF-HCD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Westlake University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ju-Sheng Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Westlake University

Locations

Westlake University

Hangzhou, Zhejiang, China

Countries

China

References

Tian Y, Ma Y, Fu Y, Zheng JS. Application of n-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR). Curr Dev Nutr. 2020 Aug 26;4(9):nzaa143. doi: 10.1093/cdn/nzaa143. eCollection 2020 Sep.

Reference Type: DERIVED

PMID: 32968703 (View on PubMed)

Other Identifiers

20190919ZJS001

Identifier Type: -

Identifier Source: org_study_id