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NCT Number: NCT04125602

Westlake N-of-1 Trials for 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.

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Key information

Conditions

Postprandial Hyperglycemia Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Metabolic Disorder, Glucose Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westlake University

Hangzhou, Zhejiang, 310024, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Fat Low Carbohydrate Diet

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.

Other names: HF-LCD

Low fat High Carbohydrate Diet

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.

Other names: LF-HCD

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Registry information

Official study title

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

Acronym: WE-MACNUTR

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2019
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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