NCT04125602|CompletedDMC
Westlake N-of-1 Trials for Macronutrient Intake
WE-MACNUTR
Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake
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WE-MACNUTR
Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake
Sponsor study identifier
interventional
30
1 country
1
Study Start
October 20, 2019
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)This is a dietary intervention study in students and staff of Westlake University, which is designed to provide evidence in support of N-of-1 methods as an approach to advance personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group level.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2019
Actual (reported)October 14, 2019
Actual (reported)October 20, 2019
Actual (reported)December 31, 2019
Actual (reported)December 31, 2019
Actual (reported)Postprandial blood glucose change
Postprandial blood glucose from different foods will be assessed.
Day 7-12 and day 19-24 of each set
Blood glucose profiling
Glucose levels will be recorded by continuous glucose monitoring over the intervention periods.
Day 7-12 and day 19-24 of each set
Fecal metabolites
Day 1, day7, day 13 and day 19 of each set
Fecal microbiota
Day 1, day7, day 13 and day 19 of each set
Metabolomics profiling
Day 1, day7, day 13 and day 19 of each set
Throughout the 6-day intervention, participants are provided with a high fat, low carbohydrate diet (HF-LCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25% respectively while the three macronutrients in the other 3-day diet account for 70%, 15% and 15% respectively. The sequencing of the two diets will be randomized.
Westlake University
Hangzhou, Zhejiang, 310024, China
Tian Y, Ma Y, Fu Y, Zheng JS. Application of n-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR). Curr Dev Nutr. 2020 Aug 26;4(9):nzaa143. doi: 10.1093/cdn/nzaa143. eCollection 2020 Sep.
Ju-Sheng Zheng, PhD
Westlake University
30 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2019
First Posted
October 14, 2019
Study Start
October 20, 2019
Actual (reported)Effects of Arm Cycling and Leg Cycling on Postprandial Blood Glucose Levels in Healthy Persons
Throughout the 6-day intervention, participants are provided with a low fat, high carbohydrate diet (LF-HCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 20%, 15% and 65% respectively while the three macronutrients in the other 3-day diet account for 10%, 15% and 75% respectively. The sequencing of the two diets will be randomized.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)Last Updated
August 5, 2020
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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