Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest

NCT04389060 | Completed

• 1 other identifier: 081-1819-EXP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction

Conditions

Obesity

Outcome Measures

Primary Outcomes (7)

• change in heart rate

  beats per minute

  2 hours after each supplementation

• change in stroke volume

  volume per stroke

  2 hours after each supplementation

• change in cardiac output

  total volume for a minute

  2 hours after each supplementation

• change in systolic blood pressure

  pressure exerted during contraction

  2 hours after each supplementation

• change in diastolic blood pressure

  pressure exerted during relaxation

  2 hours after each supplementation

• change in mean arterial pressure

  One reported pressure (systolic blood pressure-diastolic blood pressure)/3 + diastolic blood pressure

  2 hours after each supplementation

• change in total peripheral resistance

  One reported value (mean arterial pressure/cardiac output)

  2 hours after each supplementation

Study Arms (2)

GSE group

ACTIVE COMPARATOR

Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing

Dietary Supplement: Grape seed extract

Placebo group

PLACEBO COMPARATOR

Subjects took a single dose of 600 mg starch in capsule form through ingestion 2 hours prior to testing

Dietary Supplement: Grape seed extract

Interventions

Grape seed extract DIETARY_SUPPLEMENT

Two capsule grape seed extract (total 600 mg)

GSE group; Placebo group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Obesity: body mass index (\>30), Normal body weight: body mass index (25-29)

You may not qualify if:

• cardiovascular diseases or consume any antihypertensive medication or supplementation that can affect blood pressure or aortic stiffness

Sponsors & Collaborators

• California Baptist University: lead

Study Sites (1)

California Baptist University

Riverside, California, 92504, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Grape Seed Extract

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind, cross-over design
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 15, 2020
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

US (1)