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

Obesity Adult Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465110
• Other study ID #: 109-1819-EXP
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: April 22, 2020

Study information

• Verified date: July 2020
• Source: California Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 22, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity Adult Onset

Intervention

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

Locations

Country	Name	City	State
United States	California Baptist University	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
California Baptist University

Country where clinical trial is conducted

United States, 

Outcome

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