NCT04465110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

July 6, 2020

Last Update Submit

July 9, 2020

Conditions

Obesity Adult Onset

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

GSE group

EXPERIMENTAL

Subjects took a single dose of 600 mg GSE in capsule form through ingestion 7 days

Dietary Supplement: Grape Seed Extract

Placebo group

PLACEBO COMPARATOR

Subjects took a single dose of 600 mg starch in capsule form through ingestion 7 days

Dietary Supplement: Grape Seed Extract

Interventions

Grape Seed ExtractDIETARY_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

GSE groupPlacebo group

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Baptist University

Riverside, California, 92504, United States

Location

Related Publications (1)

  • 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.

    PMID: 33905304DERIVED

MeSH Terms

Interventions

Grape Seed Extract

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical Preparations

Study Officials

  • Jong-Kyung Kim, Ph.D

    California Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 9, 2020

Study Start

September 1, 2019

Primary Completion

April 22, 2020

Study Completion

April 22, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
All data will be available after publication
Access Criteria
People can access the data based on the copyright of a journal after its publication.
More information

Locations

US(1)