Effect of an Extract From the Wine Industry on Blood Pressure (HYPERGRAPES)

NCT04992936 | Completed

• 1 other identifier: HYPERGRAPES
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

By-products from the wine industry pose serious problems of management, both from an economic and environmental point of view. Although traditionally the use of by-products of the wine sector has been limited to the production of biogas and energy, or its use as animal feed or agricultural fertilizer, there is greater interest in the use of these by-products as a potential source of functional ingredients. Cardiovascular diseases (CVD) are the main cause of mortality in Europe, with hypertension being one of the main CVD risk factors. It has been shown that lowering blood pressure through behavioral and pharmacological interventions significantly improves CVD. Currently, one of the most widely used pharmacological therapies to treat hypertension is based on the use of angiotensin converting enzyme (ACE) inhibitors such as Captopril or Enalapril. ACE plays a key role in arterial pressure regulation, catalyzing the production of angiotensin II, an octapeptide with potent vasoconstrictor activity. In addition, ACE catalyzes the inactivation of bradykinin, peptide with vasodilator activity. The evaluation of various potential by-products of the wine industry for the generation of functional ingredients showed that an extract from the wine industry presented beneficial effects on blood pressure in in vitro models as well as in vivo models using rats with hypertension.

Conditions

Cardiovascular Diseases; Hypertension

Keywords

Blood pressure; wine; by-products

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure

  Systolic blood pressure will be measured using an automatic sphygmomanometer.

  Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).

Secondary Outcomes (22)

• Change in diastolic blood pressure

  Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).

• Change in body weight

  Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).

• Height

  At week 1.

• Change in BMI

  Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).

• Changes in waist circumference

  Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).

Study Arms (2)

Extract from the wine industry

EXPERIMENTAL

Participants will consume the extract from the wine industry for 5 weeks.

Dietary Supplement: Extract from the wine industry

Placebo

PLACEBO COMPARATOR

Participants will consume maltodextrin for 5 weeks.

Dietary Supplement: Placebo

Interventions

Extract from the wine industry DIETARY_SUPPLEMENT

The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.

Extract from the wine industry

Placebo DIETARY_SUPPLEMENT

The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years of age.
• Systolic blood pressure between 130- 159 mm Hg.
• Not under pharmacological treatment or have completed pharmacological treatment at least one month before the start of the study with anti-hypertensive and/or with lipid-lowering drugs. 2. Sign the informed consent.

You may not qualify if:

• BMI ≥ 35 kg/m\^2.
• Have a clinical history of chronic kidney disease, cardiovascular disease and/or cancer.
• Present diabetes.
• Take supplements with polyphenol components or aimed to lipid or blood pressure control during their participation in the study.
• Take 2 or more Standard Beverage Units daily or 17 weekly for women, or take 4 or more Standard Beverage Units daily or 28 weekly for men.
• Present some chronic gastrointestinal disease.
• Present food intolerances and/or allergies related to the products of the study, such as hypersensitivity to maltodextrin and/or sulfites.
• Being pregnant or intending to become pregnant.
• Be in breastfeeding period.
• Being unable to follow the study guidelines.

Sponsors & Collaborators

• Fundació Eurecat: lead
• University Rovira i Virgili: collaborator
• Grandes Vinos y Viñedos S.A.: collaborator

Study Sites (1)

Eurecat

Reus, 43204, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Josep M Del Bas, PhD

  UTNS (Eurecat-Reus)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: August 5, 2021
• Study Start: August 26, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The data will be shared once the intervention period with the study participants has finished and will be shared until the end of the study analysis.
• Access Criteria: The data will be encoded and access to the data will be controlled to only authorized personnel.

Locations

ES (1)