Westlake University
Hangzhou, Zhejiang, 310024, China
NCT Number: NCT05161182
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.
Looking for future studies?
Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310024, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 20 days
Real-time blood glucose fluctuations will be recorded by CGM.
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.
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.
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.
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.
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.
Time frame: Day 5 of the study
Body composition (fat mass, lean mass in kg ) will be assessed by bioelectrical impedance analysis.
Westlake University
Other
Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake 2
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.
Published trials that share one or more normalized conditions with this study.
NCT04125602
Glucose Metabolism Disorders, Hyperglycemia
Hangzhou, Zhejiang, China
View Trial DetailsNCT05581043
Acid-Base Imbalance, Acidosis
Aarhus, Denmark
View Trial DetailsNCT06878781
Behavior, Fasting
Mexico City, Mexico
View Trial DetailsNCT03836495
Energy Expenditure, Glucose Metabolism Disorders
Beirut, Lebanon
View Trial Details