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Grape Pomace Polyphenols and Cardiometabolic Risk (GRAPOM)

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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

Tracking Information
First Submitted Date  ICMJE February 26, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date April 5, 2018
Actual Study Start Date  ICMJE March 10, 2017
Actual Primary Completion Date July 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Fasting insulin [ Time Frame: Up to three months ]
    Changes of blood insulin fasting levels as result of long-term supplementation with grape pomace (GRAPOM).
  • Fasting glucose [ Time Frame: Up to three months ]
    Changes of blood glucose fasting levels as result of long-term supplementation with grape pomace (GRAPOM).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03076463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • 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).
  • 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).
  • Blood pressure [ Time Frame: Up to four months ]
    Changes of blood pressure as result of long-term supplementation with grape pomace (GRAPOM).
  • 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).
  • Blood triglycerides [ Time Frame: Up to four months ]
    Changes of blood triglycerides as result of long-term supplementation with grape pomace (GRAPOM).
  • 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).
  • Blood fibrinogen [ Time Frame: Up to five months ]
    Changes of blood fibrinogen as result of long-term supplementation with grape pomace (GRAPOM).
  • Blood uric acid [ Time Frame: Up to five months ]
    Changes of blood uric acid as result of long-term supplementation with grape pomace (GRAPOM).
  • 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).
  • Blood polyphenols [ Time Frame: Up to six months ]
    Changes of blood polyphenols as result of long-term supplementation with grape pomace (GRAPOM).
  • Urine uric acid [ Time Frame: Up to six months ]
    Changes of urine uric acid as result of long-term supplementation with grape pomace (GRAPOM).
  • Urine polyphenols [ Time Frame: Up to seen months ]
    Changes of urine polyphenols as result of long-term supplementation with grape pomace (GRAPOM).
  • 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).
  • Body fat [ Time Frame: Up to seven months ]
    Changes of body fat as result of long-term supplementation with grape pomace (GRAPOM).
  • 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).
  • Profile of fecal microbiota [ Time Frame: Up to nine months ]
    Changes of fecal microbiota as result of long-term supplementation with grape pomace (GRAPOM).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Grape Pomace Polyphenols and Cardiometabolic Risk
Official Title  ICMJE Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Subjects at Cardiometabolic Risk
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: GRAPOM
  • No Intervention: CTR
    Follow-up for 6 weeks without intervention. Samples will be collected at the beginning and the end of this period
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2018)
49
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2017)
50
Actual Study Completion Date  ICMJE December 20, 2017
Actual Primary Completion Date July 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03076463
Other Study ID Numbers  ICMJE AGL2014-55102-JIN_2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jara Pérez-Jiménez, National Research Council, Spain
Study Sponsor  ICMJE National Research Council, Spain
Collaborators  ICMJE Basque Country University
Investigators  ICMJE Not Provided
PRS Account National Research Council, Spain
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP