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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Postprandial Hyperglycemia Metabolic Disorder, Glucose Other: High fat low carbohydrate diet Other: Low fat high carbohydrate diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake
Actual Study Start Date : October 20, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

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 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

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 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




Primary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125602


Locations
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China, Zhejiang
Westlake University
Hangzhou, Zhejiang, China, 310024
Sponsors and Collaborators
Westlake University
Investigators
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Principal Investigator: Ju-Sheng Zheng, PhD Westlake University
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Responsible Party: Westlake University
ClinicalTrials.gov Identifier: NCT04125602    
Other Study ID Numbers: 20190919ZJS001
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Westlake University:
Personalized Nutrition
Glucose Metabolism
Gut Microbiota
Additional relevant MeSH terms:
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Hyperglycemia
Metabolic Diseases
Glucose Metabolism Disorders