Study to Investigate the Potential Health Benefits of Grapes Seeds Extract Supplementation in the Management of Elevated Blood Pressure or Stage 1 Hypertension

NCT06982365 | Completed DMC

• 1 other identifier: LUMHS/REC/-734/12.05.2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pragmatic, randomized, double-blind, placebo-controlled trial aimed at evaluating the potential health benefits of Enovita® (standardized grape seed extract) supplementation in adults with elevated blood pressure or Stage 1 hypertension. The primary objective is to assess the impact of Enovita® on systolic and diastolic blood pressure over 8 weeks. Secondary outcomes include changes in mood, emotional well-being, perceived stress, lipid profile, and systemic inflammation. The study will also monitor the safety and tolerability of Enovita®.

Conditions

Hypertension; Elevated Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Change in Systolic and Diastolic Blood Pressure

  Evaluation of the change in systolic and diastolic blood pressure (measured in mmHg) from baseline (Week 0) to the end of the study (Week 8). Blood pressure will be measured using a validated automatic sphygmomanometer in a seated position, following standardized protocols.

  Baseline (Week 0) and Week 8.

Secondary Outcomes (5)

• Change in Mood (Positive and Negative Affect Schedule - PANAS Total Score)

  Baseline and Week 8.

• Change in Perceived Stress (Perceived Stress Questionnaire - PSQ-30 Total Score)

  Baseline and Week 8.

• Change in Lipid Profile

  Baseline and Week 8.

• Change in Systemic Inflammation (hs-CRP Levels)

  Baseline and Week 8.

• Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Enovita®)

  Baseline to Week 8.

Study Arms (2)

Enovita® Group (Grape Seed Extract)

EXPERIMENTAL

Participants in this group will receive Enovita®, a standardized grape seed extract. Each participant will take 150 mg of Enovita® orally, twice daily (total daily dose: 300 mg) for a duration of 8 weeks.

Dietary Supplement: Enovita® (Grape Seed Extract)

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive a matching placebo capsule, identical in appearance to the Enovita® capsule. Each participant will take one placebo capsule orally, twice daily, for a duration of 8 weeks.

Other: Placebo Capsule

Interventions

Enovita® (Grape Seed Extract) DIETARY_SUPPLEMENT

Enovita® is a standardized grape seed extract containing polyphenols, known for their antioxidant and vasodilatory properties. Participants in this group will take 150 mg of Enovita® orally, twice daily (total daily dose: 300 mg) for 8 weeks.

Enovita® Group (Grape Seed Extract)

Placebo Capsule OTHER

Participants in this group will receive a matching placebo capsule identical in appearance to the Enovita® capsule, taken orally, twice daily for 8 weeks.

Also known as: Matching Placebo Capsule

Placebo Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 30 to 65 years.
• Diagnosed with Elevated Blood Pressure (systolic 120-129 mmHg and diastolic \<80 mmHg) or Stage 1 Hypertension (systolic 130-139 mmHg or diastolic 80-89 mmHg), according to American Heart Association guidelines.
• No use of antihypertensive medication in the past 3 months.
• Willing to comply with study procedures and follow-up visits.
• Able to provide written informed consent.

You may not qualify if:

• Stage 2 Hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) at screening.
• Chronic kidney disease (eGFR \< 60 mL/min/1.73 m²).
• Diabetes mellitus (HbA1c ≥ 6.5%).
• History of cardiovascular events (myocardial infarction, stroke) in the past 6 months.
• Known allergy to grape products.
• Current use of polyphenol supplements or similar herbal products.
• Pregnancy or breastfeeding.
• Participation in another clinical trial within the last 30 days.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead

Study Sites (1)

Liaquat University of Medical & Health Sciences (LUMHS)

Jāmshoro, Sindh, 76090, Pakistan

Location

Related Publications (2)

• Schon C, Allegrini P, Engelhart-Jentzsch K, Riva A, Petrangolini G. Grape Seed Extract Positively Modulates Blood Pressure and Perceived Stress: A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Volunteers. Nutrients. 2021 Feb 17;13(2):654. doi: 10.3390/nu13020654.

  PMID: 33671310 BACKGROUND

• Belcaro G, Ledda A, Hu S, Cesarone MR, Feragalli B, Dugall M. Grape seed procyanidins in pre- and mild hypertension: a registry study. Evid Based Complement Alternat Med. 2013;2013:313142. doi: 10.1155/2013/313142. Epub 2013 Sep 19.

  PMID: 24171039 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Grape Seed Extract

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and study personnel (care providers, investigators, and outcome assessors) will be blinded to group allocation. The Enovita® and placebo capsules will be identical in appearance, packaging, and labeling to ensure blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental medicine

Model Details: A randomized, double-blind, placebo-controlled, parallel-group design. Participants are randomly assigned to one of two groups: Group 1: Enovita® (Grape Seed Extract) 150 mg twice daily. Group 2: Placebo (Matching capsule) twice daily.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 21, 2025
• Study Start: August 1, 2025
• Primary Completion: November 7, 2025
• Study Completion: November 27, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)