Westlake N-of-1 Trials for Macronutrient Intake

Postprandial Hyperglycemia Clinical Trial

— WE-MACNUTR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125602
• Other study ID #: 20190919ZJS001
• Status: Completed
• Phase: N/A
• Start date: October 20, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2019
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Hyperglycemia
• Metabolic Diseases
• Metabolic Disorder, Glucose
• Postprandial Hyperglycemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Westlake University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Westlake University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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-a), 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
Other	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
Other	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
Primary	Postprandial blood glucose change	Postprandial blood glucose from different foods will be assessed.	Day 7-12 and day 19-24 of each set
Primary	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