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

Westlake University

Status

Completed

Conditions

Postprandial Hyperglycemia

Metabolic Disorder, Glucose

Treatments

Other: High fat, low carbohydrate diet

Other: Low fat, high carbohydrate diet

Study type

Interventional

Funder types

Other

Identifiers

NCT05161182

20211011ZJS001

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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