Westlake N-of-1 Trials for Macronutrient Intake 2 ( WE-MACNUTR 2)
- Conditions
- Postprandial HyperglycemiaMetabolic Disorder, Glucose
- Interventions
- Other: High fat, low carbohydrate dietOther: Low fat, high carbohydrate diet
- Registration Number
- NCT05161182
- Lead Sponsor
- Westlake University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High fat, low carbohydrate diet High fat, low carbohydrate diet - Low fat, high carbohydrate diet Low fat, high carbohydrate diet -
- Primary Outcome Measures
Name Time Method Blood glucose profiling 20 days Real-time blood glucose fluctuations will be recorded by CGM.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Westlake University
🇨🇳Hangzhou, Zhejiang, China