NCT05161182|CompletedDMC
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
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Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake 2
Sponsor study identifier
interventional
11
1 country
1
Study Start
October 30, 2021
Actual (reported)Primary Completion
November 18, 2021
Actual (reported)Study Completion
November 19, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 19, 2021
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 30, 2021
Actual (reported)November 18, 2021
Actual (reported)November 18, 2021
Actual (reported)November 19, 2021
Actual (reported)December 17, 2021
Actual (reported)Blood glucose profiling
Real-time blood glucose fluctuations will be recorded by CGM.
20 days
Urines untargeted metabolomics profiling
Day 6, day 11 day 16 and day 21 of the study
Fecal targeted metabolomics profiling
Day 6, day 11 day 16 and day 21 of the study
Microbiome taxonomic profiling
Day 6, day 11 day 16 and day 21 of the study
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.
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.
Westlake University
Hangzhou, Zhejiang, 310024, China
Ju-Sheng Zheng, PhD
Westlake University
11 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2021
First Posted
December 17, 2021
Study Start
October 30, 2021
Actual (reported)Evaluation of OxxyneaGS in Acute Glycemic Regulation on Light Hyperglycemic Subjects
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
November 18, 2021
Actual (reported)Study Completion
November 19, 2021
Actual (reported)Last Updated
June 1, 2022
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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