Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses to Exercise in Obese Males

Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses in Obese/Overweight Males During Submaximal Exercise

It was demonstrated that acute dietary supplementation with GSE reduced arterial blood pressure via reduction in Q in obese individuals. However, no studies have investigated the chronic effects of dietary GSE supplementation on hemodynamic responses during exercise. Given the fact that obesity is associated with an impaired function of eNOS, the effect of chronic dietary GSE supplementation on abnormal blood pressure response to exercise and aortic stiffness (AoS) needs be elucidated. Thus, it is hypothesized that GSE decreases systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Q, and aortic stiffness at rest and during exercise. This study would determine that this supplementation may be used as a non-pharmacological intervention to prevent incident hypertension and cardiovascular events during exercise via enhanced endothelial function.

Study Overview

• Status: Completed
• Conditions: Obesity Adult Onset
• Intervention / Treatment: Dietary supplement: Grape Seed Extract

Detailed Description

We investigated whether elevated blood pressure and aortic stiffness (AoS) characterized in obese and overweight males (N=10) are reduced following chronic GSE supplementation during exercise. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total vascular conductance (TVC), and AoS to two submaximal cycling exercises (40% and 60% VO2peak) were compared 7 days after ingestion of GSE or placebo (PL) within an one week washout period. Compared with PL, GSE supplementation significantly decreased MAP at rest, 40%, and 60% workloads. AoS was significantly reduced at rest. Q tended to be decreased, but there was no significant difference. GSE had no effect on HR, TVC, and SV. Our study indicates that chronic supplementation with GSE reduces arterial pressure at rest and during exercise primarily via the combined reduction of AoS and Q. Thus, GSE can be a dietary supplement to treat augmented blood pressure responses in obese and overweight males at rest and during exercise.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92504
      • California Baptist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Overweight: 25-29.9 kg/m2
• Obese: > 30 kg/m2
• Waist circumference: > 90 cm

Exclusion Criteria:

• Antihypertensive medication
• Major systemic disease (cancer)
• Musculoskeletal diseases
• Cardiovascular diseases or symptoms including chest pain
• Myocardial infarction
• Arrhythmias
• Heart failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GSE group; Subjects took a single dose of 600 mg GSE in capsule form through ingestion 7 days	Dietary supplement: Grape Seed Extract; Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Dietary Supplement: Grape seed extract Two capsule grape seed extract (total 600 mg) per day
PLACEBO_COMPARATOR: Placebo group; Subjects took a single dose of 600 mg starch in capsule form through ingestion 7 days	Dietary supplement: Grape Seed Extract; Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Dietary Supplement: Grape seed extract Two capsule grape seed extract (total 600 mg) per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in heart rate at rest and during exercise	beats per minute	7 day supplementation
change in stroke volume at rest and during exercise	volume per stroke	7 day supplementation
change in cardiac output at rest and during exercise	total volume for one minute	7 day supplementation
change in systolic blood pressure at rest and during exercise	pressure exerted during contraction	7 day supplementation
change in diastolic blood pressure at rest and during exercise	pressure exerted during relaxation	7 day supplementation
change in total vascular conductance at rest and during exercise	one reported value (cardiac output/mean arterial pressure)	7 day supplementation
change in aortic stiffness at rest	Arbitrary unit	7 day supplementation

Collaborators and Investigators

• Sponsor: California Baptist University

Publications and helpful links

General Publications

• Dillon K, Shariffi B, Gillum T, Boyer W, Sullivan S, Kim JK. Effects of chronic dietary grape seed extract supplementation on aortic stiffness and hemodynamic responses in obese/overweight males during submaximal exercise. Eur J Sport Sci. 2022 Jul;22(7):1057-1064. doi: 10.1080/17461391.2021.1923815. Epub 2021 May 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): April 22, 2020
• Study Completion (ACTUAL): April 22, 2020

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (ACTUAL): July 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Antioxidants; Grape Seed Extract
• Other Study ID Numbers: 109-1819-EXP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To determine the chronic effects of dietary grape seed extraction, all data collected at rest and during exercise will be shared with other researchers in the publication
• IPD Sharing Time Frame: All data will be available after publication
• IPD Sharing Access Criteria: People can access the data based on the copyright of a journal after its publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No