Inflammation Clinical Trial
Official title:
Short-term Effects of Mediterranean or Fast Food Diet on HDL Composition and Function
Verified date | August 2021 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to generate preliminary data on the effects of a short-term diet of either fast food or Mediterranean type diet on HDL and microbiota composition and function in healthy subjects, which includes both normal weight and overweight/obese subjects.
Status | Completed |
Enrollment | 10 |
Est. completion date | July 1, 2019 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 30 Years |
Eligibility | Inclusion Criteria: - 19-30 years old (women and men) - Weigh 133 pounds (60.5kg) or more - Currently consuming fast food 4 times per week or less - Categorized in "any" of the following BMI ranges: 1. BMI: 18.5-25 kg/m², for the group of healthy subjects with optimal body weight 2. BMI: 26-35 kg/m², for the group of overweight/obese subjects - Willing to consume a healthy diet (i.e. low saturated fat, low refined carbohydrate, high fruit and vegetable, high fiber) for 4 days. - Willing to consume a fast food diet (i.e. high saturated fat, high refined carbohydrate, low fruit and vegetable, low fiber) for 4 days, including a beef burger twice a day - Willing to bring all unfinished food (except beverages) back to Ragle facility in a plastic Ziploc bag. - Willing to bring in receipts from fast food purchases Exclusion Criteria: - Smoker - Anemia - Food allergies - Intolerance to dairy or gluten - Pregnant or lactating - Irregular menstrual cycle - Change in hormonal contraceptive use within the previous 3 months - Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer (active), or previous cardiovascular events - Current consumption more than 1 alcoholic drink/day - Current consumption of fast food more than 4 times per week - Fish consumption greater than or equal to 3 times per week - Extreme dietary or exercise patterns - Recent weight fluctuations (greater than 10% in the last six months) - Taking prescription lipid medications (e.g. statins) or other supplements known to alter lipoprotein metabolism such as isoflavones. - Visit 1 baseline glucose: >100 mg/dL - Regular use (> 1 time per week) of allergy or pain medications |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Ragle Center for Human Nutrition | Davis | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Zhu C, Sawrey-Kubicek L, Beals E, Hughes RL, Rhodes CH, Sacchi R, Zivkovic AM. The HDL lipidome is widely remodeled by fast food versus Mediterranean diet in 4 days. Metabolomics. 2019 Aug 17;15(8):114. doi: 10.1007/s11306-019-1579-1. — View Citation
Zhu C, Sawrey-Kubicek L, Beals E, Rhodes CH, Houts HE, Sacchi R, Zivkovic AM. Human gut microbiome composition and tryptophan metabolites were changed differently by fast food and Mediterranean diet in 4 days: a pilot study. Nutr Res. 2020 May;77:62-72. d — View Citation
Zhu C, Wong M, Li Q, Sawrey-Kubicek L, Beals E, Rhodes CH, Sacchi R, Lebrilla CB, Zivkovic AM. Site-Specific Glycoprofiles of HDL-Associated ApoE are Correlated with HDL Functional Capacity and Unaffected by Short-Term Diet. J Proteome Res. 2019 Nov 1;18( — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HDL ApoA-I content | Measure the concentration of ApoA-I in isolated HDL by ELISA | 24 months | |
Secondary | HDL lipidomic composition | Measure lipidomic composition of isolated HDL by LC-MS | 24 months | |
Secondary | HDL proteomic composition | Measure proteomic composition of isolated HDL by LC-MS | 24 months | |
Secondary | HDL cholesterol efflux capacity | Measure capacity of isolated HDL to efflux cholesterol out of macrophages | 24 months | |
Secondary | HDL anti-inflammatory capacity | Measure capacity of isolated HDL to modify cytokine secretion in macrophages | 24 months | |
Secondary | Gut microbiome changes | Measure gut microbiota composition by 16S sequencing of stool samples | 24 months |
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