NCT01674231

Brief Summary

The investigators hope to learn about the effects of whole grapes, in the form of freeze-dried grape powder, on markers of health. Phytochemical rich food consumption is associated with protection against chronic diseases such as cardiovascular disease (CVD) demonstrating the ability to modify endothelial function and lipemia, but exact causal mechanisms are still not well understood. The investigators will examine metabolic and mechanistic effects of consumption of whole grape powder in chronic as well as acute settings in response to meal challenges by testing blood samples to determine if markers of health have improved. The central hypothesis of this project is that consumption of grapes in the form of a polyphenol-rich freeze-dried whole grape powder (WGP) will attenuate chronic and meal induced oxidative stress and inflammatory responses in obese individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

August 23, 2012

Last Update Submit

May 25, 2017

Conditions

ObesityInflammationCardiovascular DiseaseOxidative Stress

Outcome Measures

Primary Outcomes (5)

  • Decrease inflammatory markers

    High sensitivity C reactive protein, TNF-alpha, IL-1beta, lL-6. Assessed at time 0, 1, 3, 5 hours of acute meal challenge and in fasting samples at the end of the intervention.

    After 4 week intervention

  • Decrease oxidative stress

    Oxidized low density lipoprotein, urinary F2-isoprostane.

    After 4 week intervention

  • Increase endothelial function

    Blood pressure, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, ESelectin.

    After 4 week intervention

  • Improve lipid profile

    Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, apolipoproteinA1, apolipoproteinB100.

    After 4 week intervention

  • Decrease in mononuclear cell production

    TLR4, SOCS-3, NADPH oxidase subunit p47phox, Nrf-2, p50 subunit, IL-1β, MMP-9, MCP-1.

    After 4 week intervention

Study Arms (2)

Grape

ACTIVE COMPARATOR

Grapes in the form of a Freeze-dried Whole Grape Powder. 60g freeze-dried whole grape powder with 296mg polyphenols per day for 4 weeks.

Other: Grape in the form of freeze-dried whole grape powder

Sugar

PLACEBO COMPARATOR

Grape Powder Placebo. 60g control food (matched for calories, low in polyphenols, and indistinguishable from active intervention) per day for 4 weeks.

Other: Grape powder placebo

Interventions

Grape in the form of freeze-dried whole grape powderOTHER

60g freeze-dried whole grape powder with 296mg polyphenols per day for 4 weeks.

Grape
Grape powder placeboOTHER

60g control food (matched for calories, low in polyphenols, and indistinguishable from active intervention) per day for 4 weeks.

Sugar

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18 years of age or older in good health
  • BMI \>30

You may not qualify if:

  • Smokers
  • Chronic disease, such as diabetes, cancer, and renal, liver or thyroid dysfunction
  • History of gastrointestinal disease
  • History of cardiovascular events
  • If pregnant or lactating
  • Regular users of statin drugs, aspirin, anti-inflammatory medications, antioxidants or botanical supplements
  • Allergy to grapes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragle Human Nutrition Center

Davis, California, 95616, United States

Location

Related Publications (1)

  • Bardagjy AS, Hu Q, Giebler KA, Ford A, Steinberg FM. Effects of grape consumption on biomarkers of inflammation, endothelial function, and PBMC gene expression in obese subjects. Arch Biochem Biophys. 2018 May 15;646:145-152. doi: 10.1016/j.abb.2018.04.003. Epub 2018 Apr 9.

    PMID: 29649425DERIVED

MeSH Terms

Conditions

ObesityInflammationCardiovascular Diseases

Interventions

whole grape extract

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Francene M Steinberg, PhD, RD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 28, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)