Subjects at Cardiometabolic Risk Clinical Trial
— GRAPOMOfficial title:
Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans
| Verified date | April 2018 |
| Source | National Research Council, Spain |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 49 |
| Est. completion date | December 20, 2017 |
| Est. primary completion date | July 7, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Institute of Food Science, Technology and Nutrition (ICTAN-CSIC) | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| National Research Council, Spain | Basque Country University |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fasting insulin | Changes of blood insulin fasting levels as result of long-term supplementation with grape pomace (GRAPOM). | Up to three months | |
| Primary | Fasting glucose | Changes of blood glucose fasting levels as result of long-term supplementation with grape pomace (GRAPOM). | Up to three months | |
| Secondary | Postprandial glucose | Changes of blood glucose response after an oral glucose load as result of long-term supplementation with grape pomace (GRAPOM). | Up to four months | |
| Secondary | Postprandial insulin | Changes of blood insulin response after an oral glucose load as result of long-term supplementation with grape pomace (GRAPOM). | Up to four months | |
| Secondary | Blood pressure | Changes of blood pressure as result of long-term supplementation with grape pomace (GRAPOM). | Up to four months | |
| Secondary | Blood cholesterol (total, HDL, LDL) | Changes of blood cholesterol (total, HDL, LDL) as result of long-term supplementation with grape pomace (GRAPOM). | Up to four months | |
| Secondary | Blood triglycerides | Changes of blood triglycerides as result of long-term supplementation with grape pomace (GRAPOM). | Up to four months | |
| Secondary | Blood C reactive protein | Changes of blood C reactive protein as result of long-term supplementation with grape pomace (GRAPOM). | Up to five months | |
| Secondary | Blood fibrinogen | Changes of blood fibrinogen as result of long-term supplementation with grape pomace (GRAPOM). | Up to five months | |
| Secondary | Blood uric acid | Changes of blood uric acid as result of long-term supplementation with grape pomace (GRAPOM). | Up to five months | |
| Secondary | Iron metabolism | Changes of blood markers of iron metabolism as result of long-term supplementation with grape pomace (GRAPOM). | Up to six months | |
| Secondary | Blood polyphenols | Changes of blood polyphenols as result of long-term supplementation with grape pomace (GRAPOM). | Up to six months | |
| Secondary | Urine uric acid | Changes of urine uric acid as result of long-term supplementation with grape pomace (GRAPOM). | Up to six months | |
| Secondary | Urine polyphenols | Changes of urine polyphenols as result of long-term supplementation with grape pomace (GRAPOM). | Up to seen months | |
| Secondary | Body weight | Changes of body weight (measured at a body-impedance equipment) as result of long-term supplementation with grape pomace (GRAPOM). | Up to three months | |
| Secondary | Body fat | Changes of body fat as result of long-term supplementation with grape pomace (GRAPOM). | Up to seven months | |
| Secondary | miRNA expression | Changes of blood expression of selected miRNA as result of long-term supplementation with grape pomace (GRAPOM). | Up to eight months | |
| Secondary | Profile of fecal microbiota | Changes of fecal microbiota as result of long-term supplementation with grape pomace (GRAPOM). | Up to nine months |