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

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

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Hyperglycemia; Metabolic Disorder, Glucose
• Intervention / Treatment: Other: High fat low carbohydrate diet; Other: Low fat high carbohydrate diet

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310024
      • Westlake University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High fat low carbohydrate diet	Other: 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.; Other Names: HF-LCD; 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.; Other Names: LF-HCD
EXPERIMENTAL: Low fat high carbohydrate diet	Other: 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.; Other Names: HF-LCD; 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.; Other Names: LF-HCD

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal metabolites	Fecal metabolite extracts will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).	Day 1, day7, day 13 and day 19 of each set
Fecal microbiota	Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.	Day 1, day7, day 13 and day 19 of each set
Metabolomics profiling	Targeted metabonomics are analyzed based on urine and faeces at all visits (also based on serum in set 1).	Day 1, day7, day 13 and day 19 of each set
Laboratory markers of glucose metabolism and inflammation	insulin, leptin, adiponection, free fatty acid, Interleukin(IL)-6, IL-8, IL-10, IL-12, IL-17A, IL-1ra, tumour necrosis factor alpha (TNF-α), Lipopolysaccharide binding protein (LBP), cortisol, high-sensitivity C-reactive protein, serum amyloid A, soluble E-selectine, soluble intracellular adhesion molecule-1, plasminogen activator inhibitor-1, vascular cell adhesion molecule, monocyte chemoattractant protein (MCP)-1, adrenaline, noradrenaline, peptide YY, and neuropeptide Y are tested at all visits of set 1.	Day 1, day7, day 13 and day 19 of set 1
Lipid metabolism	Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B are tested at all visits of set 1.	Day 1, day7, day 13 and day 19 of set 1
Physiological characteristics	Weight and blood pressure are collected at all visits of set 3.	Day 1, day7, day 13 and day 19 of set 3

Collaborators and Investigators

• Sponsor: Westlake University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (ACTUAL): October 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Gut Microbiota; Glucose Metabolism; Personalized Nutrition
• Additional Relevant MeSH Terms: Hyperglycemia; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: 20190919ZJS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No