NCT04125602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 5, 2020

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

October 10, 2019

Last Update Submit

August 3, 2020

Conditions

Postprandial HyperglycemiaMetabolic Disorder, Glucose

Keywords

Personalized NutritionGlucose MetabolismGut Microbiota

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Fecal metabolites

    Day 1, day7, day 13 and day 19 of each set

  • Fecal microbiota

    Day 1, day7, day 13 and day 19 of each set

  • Metabolomics profiling

    Day 1, day7, day 13 and day 19 of each set

  • +3 more other outcomes

Study Arms (2)

High fat low carbohydrate diet

EXPERIMENTAL
Other: High fat low carbohydrate dietOther: Low fat high carbohydrate diet

Low fat high carbohydrate diet

EXPERIMENTAL
Other: High fat low carbohydrate dietOther: Low fat high carbohydrate diet

Interventions

High fat low carbohydrate dietOTHER

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.

Also known as: HF-LCD
High fat low carbohydrate dietLow fat high carbohydrate diet
Low fat high carbohydrate dietOTHER

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.

Also known as: LF-HCD
High fat low carbohydrate dietLow fat high carbohydrate diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness and capability to complete the study protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, 310024, China

Location

Related Publications (1)

  • 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.

    PMID: 32968703DERIVED

MeSH Terms

Conditions

HyperglycemiaGlucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ju-Sheng Zheng, PhD

    Westlake University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

October 20, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 5, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)