## Protocol Section
### Identification Module
**NCT ID:** NCT06428890

**Brief Title:** Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension

**Official Title:** Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension

#### Organization Study ID Info
**ID:** 030-2223-EXP
#### Organization
**Class:** OTHER
**Full Name:** California Baptist University
### Status Module
#### Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** California Baptist University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study aimed to assess the effect of the supplementation with grape seed extract (GSE) on blood pressure during static handgrip exercise and muscle metaboreflex in individuals with elevated and state 1 hypertension.

**Detailed Description:** Muscle metatoreflex (MMR) has been known to play an important role in adjusting hemodynamic responses during exercise. The reflex increases sympathetic activity to heart and blood vessels to increase blood supply to contracting skeletal muscles. On the other hand, studies demonstrated that abnormal cardiovascular responses occurred by the overactive MMR in pathological conditions such as hypertension, diabetes, and congestive heart failure. Excessive blood pressure (BP) responses to exercise induce cardiovascular events such as stroke, heart attack, and coronary artery disease. Previously, a study found that dietary supplementation with grape seed extract (GSE) reduced BP response to dynamic exercise in individuals with elevated and stage 1 hypertension (ES1H) and associated with peripheral vasodilation. However, mechanisms underlying this phenomenon are not clear. Purpose: therefore, the purpose of this study is to investigate whether chronic dietary supplementation with GSE can decrease BP responses to exercise and this observation is associated with reduced MMR. Methods: 12 ES1H males were studied. Changes in cardiac output (Q), mean arterial pressure (MAP) and total peripheral resistance (TPR) were compared between the GSE and placebo supplementations during static handgrip exercise (SHE) and post exercise muscular ischemia (PEMI). Participants completed 3 min of SHE at 40% of MVC followed by 2 min of PEMI.

### Conditions Module

**Conditions:**

- Prehypertension

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received the supplement (600 mg, capsules) via cross-over design for 7 days

**Intervention Names:**

- Dietary Supplement: Grape Seed Extract

- Dietary Supplement: Placebo

**Label:** Dietary Supplementation with Grape Seed Extract

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants received the placebo (600 mg, capsules) via cross-over design for 7 days

**Intervention Names:**

- Dietary Supplement: Grape Seed Extract

- Dietary Supplement: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dietary Supplementation with Grape Seed Extract

- Placebo

**Description:** dietary supplements that rich in polyphenolic compounds

**Name:** Grape Seed Extract

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Dietary Supplementation with Grape Seed Extract

- Placebo

**Description:** Starch

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex

**Measure:** heart rate (bpm)

**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.

**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex

**Measure:** stroke volume (ml)

**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.

**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex

**Measure:** cardiac output (l/min)

**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.

**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex

**Measure:** systolic blood pressure (mmHg)

**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.

**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex

**Measure:** diastolic blood pressure (mmHg)

**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.

**Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex

**Measure:** total peripheral resistance (mmHg/l/min)

**Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* systolic blood pressure: 120-139 mmHg and/or a diastolic blood pressure: 80-89 mmHg

Exclusion Criteria:

* taking medications that could affect cardiovascular function or BP

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Riverside

**Country:** United States

**Facility:** California Baptist University

**State:** California

**Zip:** 92504

#### Overall Officials

**Official 1:**

**Affiliation:** California Baptist University

**Name:** Jong-Kyung Kim, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** This study needs the Institutional Research Board (IRB) and participant's approvals to share the data. Without the approval, the data collected from this study will not be shared.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M29007

- Name: Prehypertension

- Relevance: HIGH

- As Found: Prehypertension

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

- ID: D000058246

- Term: Prehypertension

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M28517

- Name: Grape Seed Extract

- Relevance: HIGH

- As Found: Platelet transfusion

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T173

- Name: Grape

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000056604

- Term: Grape Seed Extract

### Misc Info Module

- Version Holder: 2024-05-31
