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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High fat, low carbohydrate diet | Experimental |
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| Low fat, high carbohydrate diet | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose profiling | Real-time blood glucose fluctuations will be recorded by CGM. | 20 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fecal targeted metabolomics profiling |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ju-Sheng Zheng, PhD | Westlake University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westlake University | Hangzhou | Zhejiang | 310024 | China |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| 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. |
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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 |
| 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 |
| 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 |
| 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 |
| Body composition | Body composition (fat mass, lean mass in kg ) will be assessed by bioelectrical impedance analysis. | Day 5 of the study |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |