Effects of Short-term Diet on HDL Composition and Function

NCT03205254 | Completed

• 2 other identifiers: 801116UCDAMZ2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification; HDL; Inflammation

Keywords

Mediterranean diet; HDL; Fast food; Gut microbiota; Inflammation

Outcome Measures

Primary Outcomes (1)

• HDL ApoA-I content

  Measure the concentration of ApoA-I in isolated HDL by ELISA

  24 months

Secondary Outcomes (5)

• HDL lipidomic composition

  24 months

• HDL proteomic composition

  24 months

• HDL cholesterol efflux capacity

  24 months

• HDL anti-inflammatory capacity

  24 months

• Gut microbiome changes

  24 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

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; Other: Fast food diet

Group B

ACTIVE COMPARATOR

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; Other: Fast food diet

Interventions

Mediterranean Diet OTHER

four days of participant-scaled isocaloric Mediterranean meals

Group A; Group B

Fast food diet OTHER

four days of participant-scaled isocaloric fast food meals

Group A; Group B

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Ragle Center for Human Nutrition

Davis, California, 95616, United States

Location

Related Publications (3)

• 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. doi: 10.1016/j.nutres.2020.03.005. Epub 2020 Mar 26.

  PMID: 32330749 RESULT

• 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(11):3977-3984. doi: 10.1021/acs.jproteome.9b00450. Epub 2019 Oct 1.

  PMID: 31545048 RESULT

• 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.

  PMID: 31422486 RESULT

MeSH Terms

Conditions

Inflammation

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Angela Zivkovic, PhD

  UC Davis Nutrition Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized two-way crossover design

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: March 28, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)