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Completed

NCT Number: NCT04465110

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

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.

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Key information

Conditions

Obesity Adult Onset

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

California Baptist University

Riverside, California, 92504, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grape seed extract

Dietary Supplement

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

Primary outcomes

  1. change in heart rate at rest and during exercise

    Time frame: 7 day supplementation

    beats per minute

  2. change in stroke volume at rest and during exercise

    Time frame: 7 day supplementation

    volume per stroke

  3. change in cardiac output at rest and during exercise

    Time frame: 7 day supplementation

    total volume for one minute

  4. change in systolic blood pressure at rest and during exercise

    Time frame: 7 day supplementation

    pressure exerted during contraction

  5. change in diastolic blood pressure at rest and during exercise

    Time frame: 7 day supplementation

    pressure exerted during relaxation

  6. change in total vascular conductance at rest and during exercise

    Time frame: 7 day supplementation

    one reported value (cardiac output/mean arterial pressure)

  7. change in aortic stiffness at rest

    Time frame: 7 day supplementation

    Arbitrary unit

Sponsors and collaborators

Lead sponsor

California Baptist University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2020
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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