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Completed

NCT Number: NCT03076463

Grape Pomace Polyphenols and Cardiometabolic Risk

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.

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Key information

Conditions

Subjects at Cardiometabolic Risk Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

GRAPOM

Dietary Supplement

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • University of the Basque Country (UPV/EHU)

Registry information

Official study title

Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans

Acronym: GRAPOM

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2017
Registry last updated
Apr 5, 2018

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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