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Effects of Short-term Diet on HDL Composition and Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03205254
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diet Modification HDL Inflammation Other: Mediterranean Diet Other: Fast food diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized two-way crossover design
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Short-term Effects of Mediterranean or Fast Food Diet on HDL Composition and Function
Actual Study Start Date : March 28, 2016
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Arm Intervention/treatment
Active Comparator: Group A
Participants randomized to group A follow the 4-day Mediterranean diet and then the 4-day fast food diet with a 4-day washout period in between.
Other: Mediterranean Diet
four days of participant-scaled isocaloric Mediterranean meals

Other: Fast food diet
four days of participant-scaled isocaloric fast food meals

Active Comparator: Group B
Participants randomized to group B follow the 4-day fast food diet and then the 4-day Mediterranean diet with a 4-day washout period in between.
Other: Mediterranean Diet
four days of participant-scaled isocaloric Mediterranean meals

Other: Fast food diet
four days of participant-scaled isocaloric fast food meals




Primary Outcome Measures :
  1. HDL ApoA-I content [ Time Frame: 24 months ]
    Measure the concentration of ApoA-I in isolated HDL by ELISA


Secondary Outcome Measures :
  1. HDL lipidomic composition [ Time Frame: 24 months ]
    Measure lipidomic composition of isolated HDL by LC-MS

  2. HDL proteomic composition [ Time Frame: 24 months ]
    Measure proteomic composition of isolated HDL by LC-MS

  3. HDL cholesterol efflux capacity [ Time Frame: 24 months ]
    Measure capacity of isolated HDL to efflux cholesterol out of macrophages

  4. HDL anti-inflammatory capacity [ Time Frame: 24 months ]
    Measure capacity of isolated HDL to modify cytokine secretion in macrophages

  5. Gut microbiome changes [ Time Frame: 24 months ]
    Measure gut microbiota composition by 16S sequencing of stool samples



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Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205254


Locations
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United States, California
UC Davis Ragle Center for Human Nutrition
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Angela Zivkovic, PhD UC Davis Nutrition Department
Publications of Results:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03205254    
Other Study ID Numbers: 801116
UCDAMZ2 ( Other Identifier: UC Davis )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, Davis:
Mediterranean diet
HDL
Fast food
Gut microbiota
Inflammation
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes