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Completed

NCT Number: NCT05161182

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westlake University

Hangzhou, Zhejiang, 310024, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High fat, low carbohydrate diet

Other

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 names: HF-LC

Low fat, high carbohydrate diet

Other

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.

Other names: LF-HC

Primary outcomes

  1. Blood glucose profiling

    Time frame: 20 days

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

Other outcomes

  1. Urines untargeted metabolomics profiling

    Time frame: Day 6, day 11 day 16 and day 21 of the study

    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.

  2. Fecal targeted metabolomics profiling

    Time frame: Day 6, day 11 day 16 and day 21 of the study

    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.

  3. Microbiome taxonomic profiling

    Time frame: Day 6, day 11 day 16 and day 21 of the study

    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.

  4. Serum metabolomics profile

    Time frame: Day 6, day 11 day 16 and day 21 of the study

    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.

  5. Lipid metabolism

    Time frame: Day 6, day 11 day 16 and day 21 of the study

    Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B will be analyzed at all visits of the study.

  6. Body composition

    Time frame: Day 5 of the study

    Body composition (fat mass, lean mass in kg ) will be assessed by bioelectrical impedance analysis.

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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