Westlake N-of-1 Trials for Macronutrient Intake 2 ( WE-MACNUTR 2)

NCT05161182 | Completed DMC

• 1 other identifier: 20211011ZJS001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Diet and nutrition are key to maintain human health. Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR) trial investigates individualized postprandial glycemic responses to different proportions of dietary fat and carbohydrates intake using an n-of-1 experimental study design. The experimental diets are isocaloric high fat, low carbohydrate (HF-LC) or low fat, high carbohydrate (LF-HC). With standardized intervention and strictly controlled eating behaviors, the WE-MACNUTR study identifies specific HC-responders and HF-responders in terms of postprandial glucose response. This is a follow-up study offered to participants who have completed the WE-MACNUTR study in 2019. Volunteers will be asked to participate in four 5-d periods while wearing glucose monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be randomly assigned. Participants will be asked to provide a fasted blood sample and to collect fecal, urine and saliva samples at each visits.

Conditions

Postprandial Hyperglycemia; Metabolic Disorder, Glucose

Keywords

Personalized Nutrition; Glucose Metabolism; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• Blood glucose profiling

  Real-time blood glucose fluctuations will be recorded by CGM.

  20 days

Other Outcomes (6)

• Urines untargeted metabolomics profiling

  Day 6, day 11 day 16 and day 21 of the study

• Fecal targeted metabolomics profiling

  Day 6, day 11 day 16 and day 21 of the study

• Microbiome taxonomic profiling

  Day 6, day 11 day 16 and day 21 of the study

Study Arms (2)

High fat, low carbohydrate diet

EXPERIMENTAL

Other: High fat, low carbohydrate diet

Low fat, high carbohydrate diet

EXPERIMENTAL

Other: Low fat, high carbohydrate diet

Interventions

High fat, low carbohydrate diet OTHER

Throughout the 5-day intervention, participants are provided with a high fat, low carbohydrate (HF-LC) diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25%, respectively.

Also known as: HF-LC

High fat, low carbohydrate diet

Low fat, high carbohydrate diet OTHER

Throughout the 5-day intervention, participants are provided with a low fat, high carbohydrate (LF-HC) diet in which the percentage of fat, protein and carbohydrate is 10%, 15% and 75%, respectively.

Also known as: LF-HC

Low fat, high carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants have completed WE-MACNUTR trial in 2019
• Participants have no traveling plans within 1 months
• Participants are able and willing to comply with the study protocol and provide informed consent

You may not qualify if:

• Refuse or are unable to provide informed consent to participate in the study
• Have long-term gastrointestinal diseases and take daily relevant medications
• Have taken antibiotics in the last 2 weeks
• Have type 2 diabetes and are taking medications or other treatments
• Have chronic or acute liver disease and are taking medications or other treatments
• Have cardiovascular diseases and are taking medications or other treatments
• Have kidney disease and are taking medications
• Suffer from chronic anxiety or depression, or other critical neuronal disorder and/or history of relevant medication
• Are pregnant or lactating, or are planning to be pregnant in the next 3 months
• Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa)
• Are vegan, or unwilling to consume foods provided in the study
• Have history of alcohol or drug addiction, or smoke above 15 cigarettes per day

Sponsors & Collaborators

• Westlake University: lead

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, 310024, China

Location

MeSH Terms

Conditions

Hyperglycemia; Glucose Metabolism Disorders

Interventions

Diet, Carbohydrate-Restricted; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

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: November 18, 2021
• First Posted: December 17, 2021
• Study Start: October 30, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 19, 2021
• Last Updated: June 1, 2022

Record last verified: 2021-10

Locations

CN (1)