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

Study Overview
=================
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.

Official Title
-----------------
Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake 2

Conditions
-----------------
Postprandial Hyperglycemia, Metabolic Disorder, Glucose

Intervention / Treatment
-----------------
* Other: High fat, low carbohydrate diet
* Other: Low fat, high carbohydrate diet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High fat, low carbohydrate diet<br> | Other: High fat, low carbohydrate diet<br>* 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.<br>* Other names: HF-LC;|
| Experimental: Low fat, high carbohydrate diet<br> | Other: Low fat, high carbohydrate diet<br>* 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.<br>* Other names: LF-HC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose profiling | Real-time blood glucose fluctuations will be recorded by CGM. | 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Personalized Nutrition, Glucose Metabolism, Gut Microbiota