Clinical trial NCT05161182: Westlake N-of-1 Trials for Macronutrient Intake 2 ( WE-MACNUTR 2)
Official title: Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Metabolic Disorder, Glucose
Keywords: Personalized Nutrition
Glucose Metabolism
Gut Microbiota
Lead sponsor: Westlake University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Blood glucose profiling
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
measure: Urines untargeted metabolomics profiling
timeFrame: Day 6, day 11 day 16 and day 21 of the study
measure: Fecal targeted metabolomics profiling
timeFrame: Day 6, day 11 day 16 and day 21 of the study
measure: Microbiome taxonomic profiling
timeFrame: Day 6, day 11 day 16 and day 21 of the study
measure: Serum metabolomics profile
timeFrame: Day 6, day 11 day 16 and day 21 of the study
measure: Lipid metabolism
timeFrame: Day 6, day 11 day 16 and day 21 of the study
measure: Body composition
timeFrame: Day 5 of the study
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: