Dried Cabernet Grapes and Cardiovascular Risk Markers

NCT03065166 | Completed

• 1 other identifier: 944091
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses the acute effects of dried Cabernet grape intake on vascular function and platelet reactivity in postmenopausal women. Previous studies from this lab and others have demonstrated acute effects on vascular function and platelet reactivity from phenolic-rich food sources. Postmenopausal women are suggested as the study group, as they are likely to have compromised vascular function due to the loss of protective estrogen, and have been the study group for past and present research projects in this lab.

Conditions

Healthy, Postmenopausal Women

Outcome Measures

Primary Outcomes (1)

• Change in Postprandial Micro-vascular Function

  To determine whether an acute intake of dried Cabernet grapes will improve vascular function, as measured using peripheral artery tonometry (PAT).

  Baseline and 2-hour measures on day 0 and day 7.

Secondary Outcomes (6)

• Platelet Aggregation

  Baseline and 2-hour measures on day 0 and day 7.

• Nitrate/Nitrite

  Baseline and 2-hour measures on day 0 and day 7.

• Baseline Complete Metabolic Panel

  Baseline measures on day 0 and day 7.

• Postprandial Complete Metabolic Panel

  2-hour measures on day 0 and day 7.

• Body Weight

  Baseline measure on day 0 and day 7.

Study Arms (2)

Raisin Treatment

EXPERIMENTAL

3.2 ounces of dried Cabernet wine grapes.

Other: Raisin Treatment; Other: Bagel Control

Bagel Control

OTHER

One 95g whole wheat bagel.

Other: Raisin Treatment; Other: Bagel Control

Interventions

Raisin Treatment OTHER

Subjects will consume 3.2oz of dried Cabernet grapes during a single intervention time point.

Bagel Control; Raisin Treatment

Bagel Control OTHER

Subjects will consume 95g of whole wheat bagel during a single intervention time point.

Bagel Control; Raisin Treatment

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal female: 50-70 years
• Women: lack of menses for at least one year and FSH 23-116.3 mlU/mL
• Subject is willing and able to comply with the study protocols.
• Subject is willing to participate in all study procedures
• BMI 25.0 - 40 kg/m2
• Weight ≥ 110 pounds

You may not qualify if:

• BMI ≥ 40 kg/m2
• Dislike or allergy for grape products and raisins
• Self-reported use of daily anticoagulation agents including aspirin, NSAIDs
• Vegan, Vegetarians, food faddists or those consuming a non-traditional diet
• Alcohol consumption \> 3 drinks/week (i.e. 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)
• Fruit consumption ≥ 2 cups/day
• Vegetable consumption ≥ 3 cups/day for females
• Fatty Fish ≥ 3 times/week
• Coffee/tea ≥ 3 cups/day
• Dark chocolate ≥ 3 oz/day
• Self-reported restriction of physical activity due to a chronic health condition
• Self-reported chronic/routine high intensity exercise
• Self-reported diabetes
• Blood pressure ≥ 140/90 mm Hg
• Self-reported renal or liver disease

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Ragle Human Nutrition Center

Davis, California, 95616, United States

Location

Study Design

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

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 27, 2017
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)