Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-06-30

Brief Summary

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Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect after an acute or chronic consumption in rodents. In this study, we aimed to investigate the effects of an acute consumption of proanthocyanidins before a breakfast meal in humans. Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape seed proanthocyanidins in humans should be elucidated as well as its activity on vascular function.

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Detailed Description

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The intervention will consist in the administration of 2 capsules containing the grape seed proanthocyanidins extract or 2 empty capsules (placebo) just before breakfast, which will consist of 100g of white bread, 75g of salami, 50g of fatty cheese, 125g of yogurt (10% fat), 25ml of olive oil and water ad libitum. The nutritional composition of this meal is as follows: 1.200 Kcal of energy content, 15% of energy from proteins, 22% from carbohydrates and 63% from fat (35% saturated fat), and 120mg of cholesterol. Blood samples will be taken at point 0.5,1,2,3 and 6 hours after breakfast. Moreover, urine samples will be collected at time 0 and 6 hours.

Conditions

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Triglyceride Metabolism Cardiovascular Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Product 1

35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)

Group Type ACTIVE_COMPARATOR

35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)

Intervention Type DIETARY_SUPPLEMENT

Control product

2 empty capsules

Group Type PLACEBO_COMPARATOR

2 empty capsules

Intervention Type OTHER

Interventions

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35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)

Intervention Type DIETARY_SUPPLEMENT

2 empty capsules

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults between the ages of 20 and 40
* Signing the informed consent

Exclusion Criteria

* Body mass index (BMI) lower than 18.5 or greater than 27 Kg/m2
* Smokers
* Regular medication
* Consumption of medication during the last week
* Following a weight-loss diet
* Vegetarians
* Abnormal glucose levels
* Diabetes
* Cardiovascular disease
* Gastrointestinal disease
* Anemia
* Nuts allergy

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes