Effects of Short-term Diet on HDL Composition and Function

Completed · Not applicable

Conditions studied: Diet Modification, HDL, Inflammation

In brief

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.

Key facts

Study ID

NCT03205254

Run by

University of California, Davis

People needed

10

Starts

2016-03-28

Expected to finish

2019-07-01

Last updated by the study team

2021-08-12

Who can join

Age: 19 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• BMI: 18.5-25 kg/m², for the group of healthy subjects with optimal body weight
• 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

You may not qualify if…

• 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

Where it is running

• UC Davis Ragle Center for Human Nutrition — Davis, California, United States

Full record on ClinicalTrials.gov

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