Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease

NCT01443884 | Completed

• 1 other identifier: 200816801-2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to determine whether grape consumption can reduce the risk of cardiovascular disease by reducing the presence of inflammatory molecules and positively altering cholesterol levels, lipid profiles, and immune cell responses.

Conditions

Obesity; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory mediators in serum

  C-reactive protein, serum amyloid A, cytokines (IL-1, IL-6, IL-8, and TNF-a), and soluble adhesion molecules (sICAM-1, sVCAM-1) will be measured.

  0, 1, 3, 4, 8, and 9 weeks

Secondary Outcomes (2)

• Change in lipid particle size and quantity

  0, 1, 3, 4, 8 and 9 weeks

• CHange in activation and proliferation of T lymphocytes

  0, 1, 3, 4, 8 and 9 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

After a 1 week baseline, volunteers will consume two packets of grape powder stirred into water for three weeks. Each packet will contain the equivalent of approximately 2 servings of fresh grapes (46 grams of powder). Following a two week washout period, volunteers will cross-over to a placebo powder.

Dietary Supplement: Grape powder, followed by placebo powder

Group 2

EXPERIMENTAL

After a 1 week baseline, volunteers will consume two packets of placebo powder stirred into water for three weeks. Following a two week washout period, volunteers will cross-over to grape powder for three weeks.

Dietary Supplement: Placebo powder followed by grape powder

Interventions

Grape powder, followed by placebo powder DIETARY_SUPPLEMENT

For three weeks, twice per day, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) stirred into water. Following a two week washout, volunteers will consume one packet of placebo powder twice per day for three weeks.

Group 1

Placebo powder followed by grape powder DIETARY_SUPPLEMENT

For three weeks, twice per day, volunteers will consume one packet of placebo powder stirred into water. Following a two week washout, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) twice per day for three weeks.

Group 2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 30 - 45 kg/m2
• Commitment to the dietary intervention and scheduled testing

You may not qualify if:

• Subjects will be excluded from this study if their blood cell counts or blood chemistry profiles are outside of the normal range
• smoking or use of tobacco products
• drink more than one alcoholic beverage per day (1 oz. distilled liquor, 3 oz. wine, or 12 oz. beer)
• taking cholesterol-lowering medications
• taking steroids for asthma or other inflammatory states
• taking thyroid-regulating drugs
• taking over-the counter weight loss products

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Obesity; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Susan Zunino, PhD

  USDA, ARS, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 12, 2011

Record last verified: 2011-12

Locations

US (1)