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This is a dietary intervention study in students and staff of Westlake University, which is designed to provide evidence in support of N-of-1 methods as an approach to advance personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group level.
This study will employ a series of individual N-of-1 trials comparing a high fat, low carbohydrate diet (HF-LC) to a low fat, high carbohydrate diet (LF-HC). Participants will enter the study on a usual diet and will have a 6-day run in period for diet planning and baseline data collection before beginning their intervention. The HF-LC or the LF-HC will be randomized as the starting intervention followed by a wash-out period lasting for 6 days with normal diet between two interventions to eliminate previous intervention effects. Then the participants will be provided with the other diet. Both HF-LC and LF-HC last for 6 days in each set which consists of two wash-out periods and two intervention periods. There will be 3 sets in this study and investigators will aggregate the results of the completed N-of-1 trials across all participants to estimate the group level impacts of HF-LC compared to LF-HC.
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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 6-day intervention, participants are provided with a high fat, low carbohydrate diet (HF-LCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25% respectively while the three macronutrients in the other 3-day diet account for 70%, 15% and 15% respectively. The sequencing of the two diets will be randomized. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial blood glucose change | Postprandial blood glucose from different foods will be assessed. | Day 7-12 and day 19-24 of each set |
| Blood glucose profiling | Glucose levels will be recorded by continuous glucose monitoring over the intervention periods. | Day 7-12 and day 19-24 of each set |
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| Measure | Description | Time Frame |
|---|---|---|
| Fecal metabolites | Fecal metabolite extracts will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS). | Day 1, day7, day 13 and day 19 of each set |
| Fecal microbiota |
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32968703 | Derived | Tian Y, Ma Y, Fu Y, Zheng JS. Application of n-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR). Curr Dev Nutr. 2020 Aug 26;4(9):nzaa143. doi: 10.1093/cdn/nzaa143. eCollection 2020 Sep. |
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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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| Low fat high carbohydrate diet | Other | Throughout the 6-day intervention, participants are provided with a low fat, high carbohydrate diet (LF-HCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 20%, 15% and 65% respectively while the three macronutrients in the other 3-day diet account for 10%, 15% and 75% respectively. The sequencing of the two diets will be randomized. |
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Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
| Day 1, day7, day 13 and day 19 of each set |
| Metabolomics profiling | Targeted metabonomics are analyzed based on urine and faeces at all visits (also based on serum in set 1). | Day 1, day7, day 13 and day 19 of each set |
| Laboratory markers of glucose metabolism and inflammation | insulin, leptin, adiponection, free fatty acid, Interleukin(IL)-6, IL-8, IL-10, IL-12, IL-17A, IL-1ra, tumour necrosis factor alpha (TNF-α), Lipopolysaccharide binding protein (LBP), cortisol, high-sensitivity C-reactive protein, serum amyloid A, soluble E-selectine, soluble intracellular adhesion molecule-1, plasminogen activator inhibitor-1, vascular cell adhesion molecule, monocyte chemoattractant protein (MCP)-1, adrenaline, noradrenaline, peptide YY, and neuropeptide Y are tested at all visits of set 1. | Day 1, day7, day 13 and day 19 of set 1 |
| Lipid metabolism | Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B are tested at all visits of set 1. | Day 1, day7, day 13 and day 19 of set 1 |
| Physiological characteristics | Weight and blood pressure are collected at all visits of set 3. | Day 1, day7, day 13 and day 19 of set 3 |