Subjects at Cardiometabolic RiskGRAPOMNCT03076463
Grape Pomace Polyphenols and Cardiometabolic Risk
A study testing GRAPOM in people with Subjects at Cardiometabolic Risk, run by National Research Council, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects at Cardiometabolic Risk
- What is being tested?
- GRAPOM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
Madrid, 28040
About this study
Official title: Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans
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.
Read the 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.
- Conditions
- Subjects at Cardiometabolic Risk
- Being tested
- GRAPOM
- Keywords
- Polyphenols, Metabolic syndrome, Cardiometabolic risk, Grape pomace, Postprandial glucose, Insulin resistance, Obesity
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRAPOMDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| GRAPOM | Experimental | 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 Receives: Dietary Supplement: GRAPOM |
| CTR | No intervention | Follow-up for 6 weeks without intervention. Samples will be collected at the beginning and the end of this period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting insulin
Changes of blood insulin fasting levels as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to three months
Fasting glucose
Changes of blood glucose fasting levels as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to three months
Secondary outcomes (16)
Postprandial glucose
Changes of blood glucose response after an oral glucose load as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to four months
Postprandial insulin
Changes of blood insulin response after an oral glucose load as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to four months
Blood pressure
Changes of blood pressure as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to four months
Blood cholesterol (total, HDL, LDL)
Changes of blood cholesterol (total, HDL, LDL) as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to four months
Blood triglycerides
Changes of blood triglycerides as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to four months
Blood C reactive protein
Changes of blood C reactive protein as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to five months
Blood fibrinogen
Changes of blood fibrinogen as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to five months
Blood uric acid
Changes of blood uric acid as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to five months
Iron metabolism
Changes of blood markers of iron metabolism as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to six months
Blood polyphenols
Changes of blood polyphenols as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to six months
Urine uric acid
Changes of urine uric acid as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to six months
Urine polyphenols
Changes of urine polyphenols as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to seen months
Body weight
Changes of body weight (measured at a body-impedance equipment) as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to three months
Body fat
Changes of body fat as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to seven months
miRNA expression
Changes of blood expression of selected miRNA as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to eight months
Profile of fecal microbiota
Changes of fecal microbiota as result of long-term supplementation with grape pomace (GRAPOM).
Measured: Up to nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start10 Mar 2017
- Primary completion7 Jul 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects at Cardiometabolic RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- University of the Basque Country (UPV/EHU)
- Responsible party
- Principal investigator, Jara Pérez-Jiménez, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076463
- Sponsor's protocol ID
- AGL2014-55102-JIN_2
- Acronym
- GRAPOM
- Status last verified
- Apr 2018
- First submitted
- 26 Feb 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans
- ClinicalTrials.gov ID
- NCT03076463
- Acronym / sponsor ID
- GRAPOM / AGL2014-55102-JIN_2
- Conditions
- Subjects at Cardiometabolic Risk
- Keywords
- Polyphenols, Metabolic syndrome, Cardiometabolic risk, Grape pomace, Postprandial glucose, Insulin resistance, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- University of the Basque Country (UPV/EHU)
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GRAPOM | Experimental | Dietary Supplement: GRAPOMDaily 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 |
| CTR | No intervention | –Follow-up for 6 weeks without intervention. Samples will be collected at the beginning and the end of this period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRAPOMThe 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. | Dietary supplement | GRAPOM |
Primary outcome
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).
16 secondary outcomes
Postprandial glucose
Time frame: Up to four months
Postprandial insulin
Time frame: Up to four months
Blood pressure
Time frame: Up to four months
Blood cholesterol (total, HDL, LDL)
Time frame: Up to four months
Blood triglycerides
Time frame: Up to four months
Blood C reactive protein
Time frame: Up to five months
Blood fibrinogen
Time frame: Up to five months
Blood uric acid
Time frame: Up to five months
Iron metabolism
Time frame: Up to six months
Blood polyphenols
Time frame: Up to six months
Urine uric acid
Time frame: Up to six months
Urine polyphenols
Time frame: Up to seen months
Body weight
Time frame: Up to three months
Body fat
Time frame: Up to seven months
miRNA expression
Time frame: Up to eight months
Profile of fecal microbiota
Time frame: Up to nine months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRAPOM in people with Subjects at Cardiometabolic Risk, run by National Research Council, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting insulin (time frame: Up to three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.