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

Postprandial Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161182
• Other study ID #: 20211011ZJS001
• Status: Completed
• Phase: N/A
• Start date: October 30, 2021
• Est. completion date: November 19, 2021

Study information

• Verified date: October 2021
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 19, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Hyperglycemia
• Metabolic Diseases
• Metabolic Disorder, Glucose
• Postprandial Hyperglycemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Westlake University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Westlake University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urines untargeted metabolomics profiling	Urine metabolite extracts will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS). Compound will be identified by retention time and relative amount.	Day 6, day 11 day 16 and day 21 of the study
Other	Fecal targeted metabolomics profiling	Fecal metabolite extracts will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS). Metabolites, L-alanine for example, will be identified in µmol/L.	Day 6, day 11 day 16 and day 21 of the study
Other	Microbiome taxonomic profiling	Stool samples will be collected on day 6, day 11 day 16 and day 21 of the study. Shotgun metagenomic sequencing will be performed in stool samples. The taxonomic profiling and the organisms' relative abundance will be quantified using MetaPhlAn.	Day 6, day 11 day 16 and day 21 of the study
Other	Serum metabolomics profile	Venous blood samples will be collected at fasting in the morning on day 6, day 11 day 16 and day 21 of the study. The liquid chromatography/mass spectrometry (LC/MS) method with targeted metabolomics will be performed in blood serum. Compound (amino acids, fatty acids and bile acids) will be identified by retention time and relative amount.	Day 6, day 11 day 16 and day 21 of the study
Other	Lipid metabolism	Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B will be analyzed at all visits of the study.	Day 6, day 11 day 16 and day 21 of the study
Other	Body composition	Body composition (fat mass, lean mass in kg ) will be assessed by bioelectrical impedance analysis.	Day 5 of the study
Primary	Blood glucose profiling	Real-time blood glucose fluctuations will be recorded by CGM.	20 days