Clinical trial NCT04465110: Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses to Exercise in Obese Males
Official title: Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses in Obese/Overweight Males During Submaximal Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Adult Onset
Lead sponsor: California Baptist University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in heart rate at rest and during exercise
timeFrame: 7 day supplementation
measure: change in stroke volume at rest and during exercise
timeFrame: 7 day supplementation
measure: change in cardiac output at rest and during exercise
timeFrame: 7 day supplementation
measure: change in systolic blood pressure at rest and during exercise
timeFrame: 7 day supplementation
measure: change in diastolic blood pressure at rest and during exercise
timeFrame: 7 day supplementation
measure: change in total vascular conductance at rest and during exercise
timeFrame: 7 day supplementation
measure: change in aortic stiffness at rest
timeFrame: 7 day supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: California Baptist University
state: California
Study officials:
affiliation: California Baptist University
name: Jong-Kyung Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.