NCT05161182

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Westlake University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2021-10-30
• Primary completion: 2021-11-18
• Completion: 2021-11-19
• First posted: 2021-12-17
• Last updated: 2022-06-01

Locations

1 site across 1 country: China