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

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ClinicalTrials.gov Identifier: NCT04125602
Recruitment Status : Completed
First Posted : October 14, 2019
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Westlake University

Tracking Information
First Submitted Date  ICMJE October 10, 2019
First Posted Date  ICMJE October 14, 2019
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE October 20, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • Postprandial blood glucose change [ Time Frame: Day 7-12 and day 19-24 of each set ]
    Postprandial blood glucose from different foods will be assessed.
  • Blood glucose profiling [ Time Frame: Day 7-12 and day 19-24 of each set ]
    Glucose levels will be recorded by continuous glucose monitoring over the intervention periods.
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
  • Postprandial blood glucose change [ Time Frame: 12 days ]
    Postprandial blood glucose from different foods will be assessed.
  • Blood glucose pattern [ Time Frame: 12 days ]
    Glucose levels will be recorded by continuous glucose monitoring over the intervention periods.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 8, 2020)
  • Fecal metabolites [ Time Frame: Day 1, day7, day 13 and day 19 of each set ]
    Fecal metabolite extracts will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).
  • Fecal microbiota [ Time Frame: Day 1, day7, day 13 and day 19 of each set ]
    Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
  • Metabolomics profiling [ Time Frame: Day 1, day7, day 13 and day 19 of each set ]
    Targeted metabonomics are analyzed based on urine and faeces at all visits (also based on serum in set 1).
  • Laboratory markers of glucose metabolism and inflammation [ Time Frame: Day 1, day7, day 13 and day 19 of set 1 ]
    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.
  • Lipid metabolism [ Time Frame: Day 1, day7, day 13 and day 19 of set 1 ]
    Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B are tested at all visits of set 1.
  • Physiological characteristics [ Time Frame: Day 1, day7, day 13 and day 19 of set 3 ]
    Weight and blood pressure are collected at all visits of set 3.
Original Other Pre-specified Outcome Measures
 (submitted: October 11, 2019)
  • Fecal metabolites [ Time Frame: 12 days ]
    Fecal metabolite extracts will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).
  • Fecal microbiota [ Time Frame: 12 days ]
    Fecal microbiota will be analyzed using 16S rRNA gene sequencing technique.
 
Descriptive Information
Brief Title  ICMJE Westlake N-of-1 Trials for Macronutrient Intake
Official Title  ICMJE Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Postprandial Hyperglycemia
  • Metabolic Disorder, Glucose
Intervention  ICMJE
  • 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 Name: 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 Name: LF-HCD
Study Arms  ICMJE
  • Experimental: High fat low carbohydrate diet
    Interventions:
    • Other: High fat low carbohydrate diet
    • Other: Low fat high carbohydrate diet
  • Experimental: Low fat high carbohydrate diet
    Interventions:
    • Other: High fat low carbohydrate diet
    • Other: Low fat high carbohydrate diet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04125602
Other Study ID Numbers  ICMJE 20190919ZJS001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Westlake University
Study Sponsor  ICMJE Westlake University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ju-Sheng Zheng, PhD Westlake University
PRS Account Westlake University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP