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Grape Pomace Polyphenols and Cardiometabolic Risk (GRAPOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076463
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Basque Country University
Information provided by (Responsible Party):
Jara Pérez-Jiménez, National Research Council, Spain

Brief Summary:
The aim of this is study is to evaluate the long-term effects of grape polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Also, studies on the long-term effect of grape polyphenol on markers of metabolic syndrome have been mostly conducted in animals, so clinical trials on this topic are needed.

Condition or disease Intervention/treatment Phase
Subjects at Cardiometabolic Risk Dietary Supplement: GRAPOM Not Applicable

Detailed Description:

Fifty supposedly healthy volunteers with at least two cardiometabolic risk factors were recruited. The cardiometabolic risk factors used to select the subjects are described below.

The whole intervention will be divided in 2 periods, control (CTR) and dried and milled grape pomace (GRAPOM). The two periods will have a duration of 6 weeks. During the CTR period, subjects will follow their normal dietary habits and samples will be collected at the beginning and at the end. No proper placebo could be found for the product, so this CTR period was chosen. During the GRAPOM period, the subjects will daily consume 8 g of the product solved in water and samples will be collected at the beginning and at the end.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: GRAPOM: dried and milled grape pomaces. CTR: control period. All the subjects will pass the two periods: one half will do the CTRL period followed by the GRAPOM period, and the other half will do it inversely. The assignment to each order will be done randomly. Both period will be separated by a four weeks washing period.
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GRAPOM
Daily consumption for 6 weeks of 10 g of dried and milled grape pomaces solved in water. Samples will be collected at the beginning and the end of this period
Dietary Supplement: GRAPOM
The whole intervention will be divided in 2 periods, control (CTR) and dried and milled grape pomace (GRAPOM). The two periods will have a duration of 6 weeks. During the CTR period, subjects will follow their normal dietary habits and samples will be collected at the beginning and at the end. No proper placebo could be found for the product, so this CTR period was chosen. During the GRAPOM period, the subjects will daily consume 8 g of the product solved in water and samples will be collected at the beginning and at the end.

No Intervention: CTR
Follow-up for 6 weeks without intervention. Samples will be collected at the beginning and the end of this period



Primary Outcome Measures :
  1. Fasting insulin [ Time Frame: Up to three months ]
    Changes of blood insulin fasting levels as result of long-term supplementation with grape pomace (GRAPOM).

  2. Fasting glucose [ Time Frame: Up to three months ]
    Changes of blood glucose fasting levels as result of long-term supplementation with grape pomace (GRAPOM).


Secondary Outcome Measures :
  1. Postprandial glucose [ Time Frame: Up to four months ]
    Changes of blood glucose response after an oral glucose load as result of long-term supplementation with grape pomace (GRAPOM).

  2. Postprandial insulin [ Time Frame: Up to four months ]
    Changes of blood insulin response after an oral glucose load as result of long-term supplementation with grape pomace (GRAPOM).

  3. Blood pressure [ Time Frame: Up to four months ]
    Changes of blood pressure as result of long-term supplementation with grape pomace (GRAPOM).

  4. Blood cholesterol (total, HDL, LDL) [ Time Frame: Up to four months ]
    Changes of blood cholesterol (total, HDL, LDL) as result of long-term supplementation with grape pomace (GRAPOM).

  5. Blood triglycerides [ Time Frame: Up to four months ]
    Changes of blood triglycerides as result of long-term supplementation with grape pomace (GRAPOM).

  6. Blood C reactive protein [ Time Frame: Up to five months ]
    Changes of blood C reactive protein as result of long-term supplementation with grape pomace (GRAPOM).

  7. Blood fibrinogen [ Time Frame: Up to five months ]
    Changes of blood fibrinogen as result of long-term supplementation with grape pomace (GRAPOM).

  8. Blood uric acid [ Time Frame: Up to five months ]
    Changes of blood uric acid as result of long-term supplementation with grape pomace (GRAPOM).

  9. Iron metabolism [ Time Frame: Up to six months ]
    Changes of blood markers of iron metabolism as result of long-term supplementation with grape pomace (GRAPOM).

  10. Blood polyphenols [ Time Frame: Up to six months ]
    Changes of blood polyphenols as result of long-term supplementation with grape pomace (GRAPOM).

  11. Urine uric acid [ Time Frame: Up to six months ]
    Changes of urine uric acid as result of long-term supplementation with grape pomace (GRAPOM).

  12. Urine polyphenols [ Time Frame: Up to seen months ]
    Changes of urine polyphenols as result of long-term supplementation with grape pomace (GRAPOM).

  13. Body weight [ Time Frame: Up to three months ]
    Changes of body weight (measured at a body-impedance equipment) as result of long-term supplementation with grape pomace (GRAPOM).

  14. Body fat [ Time Frame: Up to seven months ]
    Changes of body fat as result of long-term supplementation with grape pomace (GRAPOM).

  15. miRNA expression [ Time Frame: Up to eight months ]
    Changes of blood expression of selected miRNA as result of long-term supplementation with grape pomace (GRAPOM).

  16. Profile of fecal microbiota [ Time Frame: Up to nine months ]
    Changes of fecal microbiota as result of long-term supplementation with grape pomace (GRAPOM).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

At least two of the following requirements:

  • BMI ≥ 25 kg/m2.
  • Fasting glucose values ≥ 100 mg/dL.
  • Triglycerides ≥ 150 mg/dL.
  • HDL-cholesterol: ≤ 50 mg/dL women, ≤ 40 mg/dL men.
  • Blood pressure: systolic ≥ 130 mm Hg or diastolic ≥ 85 mm Hg.

Exclusion Criteria:

  • Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
  • Volunteers participating in other studies or weight loss plans.
  • Pregnant or breastfeeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076463


Locations
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Spain
Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
Madrid, Spain, 28040
Sponsors and Collaborators
National Research Council, Spain
Basque Country University

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Responsible Party: Jara Pérez-Jiménez, PhD, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT03076463     History of Changes
Other Study ID Numbers: AGL2014-55102-JIN_2
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jara Pérez-Jiménez, National Research Council, Spain:
Polyphenols
Metabolic syndrome
Cardiometabolic risk
Grape pomace
Postprandial glucose
Insulin resistance
Obesity
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases