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

NCT ID: NCT05161182

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-30
• Study Completion Date: 2021-11-19

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.

Detailed Description

This study is a two arm dietary intervention study. Participants will be recruited from the WE-MACNUTR study based on the defined inclusion and exclusion criteria. The study duration will last up to 21 days.

Volunteers will be asked to participate in four 5-day 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 enter the study on a usual (washout) diet and will have a 5-day run in period for baseline data collection. Participants will be asked to follow dietary guidance and consumed a healthy and balanced diet during this period.

Conditions

Postprandial Hyperglycemia; Metabolic Disorder, Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

High fat, low carbohydrate diet

Group Type: EXPERIMENTAL

High fat, low carbohydrate diet

Intervention Type: 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.

Low fat, high carbohydrate diet

Group Type: EXPERIMENTAL

Low fat, high carbohydrate diet

Intervention Type: 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.

Interventions

High fat, low carbohydrate diet

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.

Intervention Type: OTHER

Low fat, high carbohydrate diet

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.

Intervention Type: OTHER

Other Intervention Names

HF-LC; LF-HC

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Westlake University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ju-Sheng Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Westlake University

Locations

Westlake University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

20211011ZJS001

Identifier Type: -

Identifier Source: org_study_id