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

Primary Purpose

Postprandial Hyperglycemia, Metabolic Disorder, Glucose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

High fat, low carbohydrate diet

Low fat, high carbohydrate diet

About this trial

This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring Personalized Nutrition, Glucose Metabolism, Gut Microbiota

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Westlake University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High fat, low carbohydrate diet

Low fat, high carbohydrate diet

Arm Description

Outcomes

Primary Outcome Measures

Blood glucose profiling

Real-time blood glucose fluctuations will be recorded by CGM.

Secondary Outcome Measures

Full Information

NCT ID

NCT05161182

First Posted

November 18, 2021

Last Updated

May 27, 2022

Sponsor

Westlake University

1. Study Identification

Unique Protocol Identification Number

NCT05161182

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

October 30, 2021 (Actual)

Primary Completion Date

November 18, 2021 (Actual)

Study Completion Date

November 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Westlake University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postprandial Hyperglycemia, Metabolic Disorder, Glucose

Keywords

Personalized Nutrition, Glucose Metabolism, Gut Microbiota

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High fat, low carbohydrate diet

Arm Type

Experimental

Arm Title

Low fat, high carbohydrate diet

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

High fat, low carbohydrate diet

Other Intervention Name(s)

HF-LC

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Low fat, high carbohydrate diet

Other Intervention Name(s)

LF-HC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Blood glucose profiling

Description

Real-time blood glucose fluctuations will be recorded by CGM.

Time Frame

20 days

Other Pre-specified Outcome Measures:

Title

Urines untargeted metabolomics profiling

Description

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.

Time Frame