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Completed

NCT Number: NCT01688154

Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

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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Key information

Conditions

Triglyceride Metabolism Cardiovascular Function

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CTNS, Reus, Tarragona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

2 empty capsules

Other

Primary outcomes

  1. Area under the curve of plasma triglycerides concentration

    Time frame: 0-180 minutes

Secondary outcomes

  1. Blood pressure

    Time frame: 0-0.5-1-2-3-6 hours

  2. Endothelial function (assessed by ischemic reactive hyperemia)

    Time frame: 0-0.5-1-2-3-6 hours

  3. Blood lipid levels, markers of inflammation and oxidation

    Time frame: 0-0.5-1-2-3-6 hours

  4. Plasma levels of procyanidins metabolites

    Time frame: 0-0.5-1-2-3-6 hours

  5. Markers of cholesterol metabolism in PBMCs (mRNA and protein).

    Time frame: 0-0.5-1-2-3-6 hours

  6. Membrane lipid composition of erythrocytes and oxidation markers.

    Time frame: 0-0.5-1-2-3-6 hours

  7. Non-targeted metabolomics and 8-epi-prostaglandin-F2α levels (in urine)

    Time frame: 0-6 hours

Sponsors and collaborators

Lead sponsor

Technological Centre of Nutrition and Health, Spain

Other

Collaborators

  • Hospital Universitari Sant Joan de Reus
  • University Rovira i Virgili

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2012
Registry last updated
Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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