Metabolic Disorder, Glucose, Postprandial Hyperglycemia
Conditions
Keywords
Personalized Nutrition, Glucose Metabolism, Gut Microbiota
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Westlake University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Willingness and capability to complete the study protocol
Exclusion criteria
* Inability or unwillingness to approved to provide informed consent * Neurological conditions that might affect the assessment of the study measurement * Hospitalization or surgery planned within 3 months * Gastrointestinal diseases * Other serious medical conditions, such as liver, kidney, or systemic disease * Women who are pregnant or lactating * Tobacco, alcohol, or illicit drug abuse * Had taken antibiotics in the past two weeks prior to the start of the trial * Participants on a vegan diet * Any food allergy * Lack of smart phone and data plan for participating caregiver * Non-Chinese speaking participants * Participating in another concurrent intervention study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial blood glucose change | Day 7-12 and day 19-24 of each set | Postprandial blood glucose from different foods will be assessed. |
| Blood glucose profiling | Day 7-12 and day 19-24 of each set | Glucose levels will be recorded by continuous glucose monitoring over the intervention periods. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Metabolomics profiling | Day 1, day7, day 13 and day 19 of each set | Targeted metabonomics are analyzed based on urine and faeces at all visits (also based on serum in set 1). |
| Laboratory markers of glucose metabolism and inflammation | Day 1, day7, day 13 and day 19 of set 1 | 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. |
| Fecal metabolites | Day 1, day7, day 13 and day 19 of each set | Fecal metabolite extracts will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS). |
| Physiological characteristics | Day 1, day7, day 13 and day 19 of set 3 | Weight and blood pressure are collected at all visits of set 3. |
| Lipid metabolism | Day 1, day7, day 13 and day 19 of set 1 | Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B are tested at all visits of set 1. |
| Fecal microbiota | Day 1, day7, day 13 and day 19 of each set | Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing. |
Countries
China
Outcome results
None listed