Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

• Sponsor: Technological Centre of Nutrition and Health, Spain (Other)
• Overall Status: Completed
• CT.gov ID: NCT01688154
• Collaborator: University Rovira i Virgili (Other), Hospital Universitari Sant Joan de Reus (Other)
• Enrollment: 16
• Locations: 2
• Arms: 2
• Duration (Months): 3.9
• Patients Per Site: 8
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Triglyceride Metabolism; Cardiovascular Function	Dietary Supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules); Other: 2 empty capsules	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Product 1 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)	Dietary Supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)
Placebo Comparator: Control product 2 empty capsules	Other: 2 empty capsules

Outcome Measures

Primary Outcome Measures

1. Area under the curve of plasma triglycerides concentration [0-180 minutes]

Secondary Outcome Measures

1. Blood pressure [0-0.5-1-2-3-6 hours]

2. Endothelial function (assessed by ischemic reactive hyperemia) [0-0.5-1-2-3-6 hours]

3. Blood lipid levels, markers of inflammation and oxidation [0-0.5-1-2-3-6 hours]

4. Plasma levels of procyanidins metabolites [0-0.5-1-2-3-6 hours]

5. Markers of cholesterol metabolism in PBMCs (mRNA and protein). [0-0.5-1-2-3-6 hours]

6. Membrane lipid composition of erythrocytes and oxidation markers. [0-0.5-1-2-3-6 hours]

7. Non-targeted metabolomics and 8-epi-prostaglandin-F2α levels (in urine) [0-6 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CTNS	Reus	Tarragona	Spain	43204
2	Technological Center of Nutrition and Health (CTNS)	Reus	Tarragona	Spain	43204

Sponsors and Collaborators

• Technological Centre of Nutrition and Health, Spain
• University Rovira i Virgili
• Hospital Universitari Sant Joan de Reus

Investigators

• Principal Investigator: Rosa Solà, PhD, University Rovira i Virgili
• Principal Investigator: Maria Cinta Bladé, PhD, University Rovira i Virgili

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Technological Centre of Nutrition and Health, Spain
• ClinicalTrials.gov Identifier: NCT01688154
• Other Study ID Numbers: 306724
• First Posted: Sep 19, 2012
• Last Update Posted: Jul 3, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Proanthocyanidin; Procyanidin

Study Results

No Results Posted as of Jul 3, 2013