ObesityGRAPESECONDNCT03741218
Grape Polyphenols and Second-meal Effect
A study of Obesity, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The aim of this is study is to evaluate the effects of a single intake of grapes (a polyphenol-rich food) in postprandial metabolism in subjects with obesity, including a first intake (high-fat breakfast) after overnight fasting a second one (medium-fat lunch). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 10 Dec 2018to 15 Feb 2020
- 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
- Obesity (BMI = 30-40 kg/m2).
Who cannot join
- Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- Subjects with diagnoses of type 2 diabetes, cardiovascular diseases or thyroid diseases.
- Values above the following ones: glucose, > 115 mg/dL; triglycerides, > 350 mg/dL; total cholesterol, > 280 mg/dL; systolic blood pressure, > 150 mmHg; diastolic blood pressure, > 100 mmHg
- Previous bariatric surgery.
- Volunteers participating in other studies (currently or during last year) or weight loss plans.
- Pregnant or breastfeeding women.
- Adherence to vegetarian diets or usual consumption of dietary supplements.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
Madrid, 28040
About this study
Official title: Potential Modulatory Effect of Whole Grape on Second-meal Tolerance in Obese Subjects: Role of Polyphenols
The aim of this is study is to evaluate the effects of a single intake of grapes (a polyphenol-rich food) in postprandial metabolism in subjects with obesity, including a first intake (high-fat breakfast) after overnight fasting a second one (medium-fat lunch). Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used grape extracts, ignoring the whole pool of polyphenols present in grapes (extractable and non-extractable polyphenols). Besides, the contribution of polyphenols to the so-called second-meal effect has not been explored. It should be highlighted that this study aims to explore the potential beneficial role of fresh grapes, consumed as fruit; in order to ensure the stability of the product, they will be provided as freeze-dried milled material, but the amount received by the subjects could be incorporated into a common diet, being equivalent to 300 g of fresh grapes.
Read the detailed description
Twenty-five subjects with obesity will be were recruited. Detailed inclusion and exclusion criteria are provided below.
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. Both interventions will be separated by two weeks. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, viscosity, antioxidant capacity. Additionally, a satiety test will be provided. It is expected that grape supplementation, as compared with an isocaloric placebo, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the area under the curve for glucose after the second meal (300-420 min from basal time).
- Conditions
- Obesity
- Being tested
- Freeze-dried grape (GRAP)/Placebo (PLA)
- Keywords
- Polyphenols, Obesity, Grape, Postprandial, Insulin resistance, Second meal effect
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried grape (GRAP)/Placebo (PLA)Other
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. A total of 10 samples will be collected: 0-30-60-120-180-240-300-330-360-420 min. Both interventions will be separated by two weeks. Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects will receive a high-fat breakfast and a medium-fat lunch twice. They will consume together with the breakfast the placebo (PLA) the first time and grape (GRAP) the second time. Receives: Other: Freeze-dried grape (GRAP)/Placebo (PLA) |
| 2 | Experimental | All subjects will receive a high-fat breakfast and a medium-fat lunch twice. They will consume together with the breakfast grape (GRAP) the first time and the placebo (PLA) the second time. Receives: Other: Freeze-dried grape (GRAP)/Placebo (PLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose (300-420 min)
Changes of postprandial blood glucose as result of supplementation with grapes, measured area under the curve for the period 300-420 min
Measured: Up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start10 Dec 2018
- Primary completion1 Nov 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- GRAP: dried and milled grape pomaces. PLA: control period. All the subjects will pass the two periods: one half will receive the acute PLA supplementation followed by the acute GRAP supplementation, and the other half will do it inversely. The assignment to each order will be done randomly. Both period will be separated by a two weeks washing period.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- California Table Grape Commission
- Responsible party
- Principal investigator, Jara Pérez-Jiménez, National Research Council, Spain
- Investigators
- Jara Pérez-Jiménez, PhD, Principal investigator, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741218
- Sponsor's protocol ID
- HRG_2018
- Acronym
- GRAPESECOND
- Status last verified
- Feb 2020
- First submitted
- 13 Nov 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Diez E, Cuesta-Hervas M, Veses-Alcobendas AM, Alonso-Gordo O, Garcia-Maldonado E, Martinez-Suarez M, Herranz B, Vaquero MP, Alvarez MD, Perez-Jimenez J. Acute supplementation with grapes in obese subjects did not affect postprandial metabolism: a randomized, double-blind, crossover clinical trial. Eur J Nutr. 2021 Aug;60(5):2671-2681. doi: 10.1007/s00394-020-02451-6. Epub 2021 Jan 2.
PubMed 33386890
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Modulatory Effect of Whole Grape on Second-meal Tolerance in Obese Subjects: Role of Polyphenols
- ClinicalTrials.gov ID
- NCT03741218
- Acronym / sponsor ID
- GRAPESECOND / HRG_2018
- Conditions
- Obesity
- Keywords
- Polyphenols, Obesity, Grape, Postprandial, Insulin resistance, Second meal effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- California Table Grape Commission
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 14 Nov 2018 (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 effects of a single intake of grapes (a polyphenol-rich food) in postprandial metabolism in subjects with obesity, including a first intake (high-fat breakfast) after overnight fasting a second one (medium-fat lunch). Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used grape extracts, ignoring the whole pool of polyphenols present in grapes (extractable and non-extractable polyphenols). Besides, the contribution of polyphenols to the so-called second-meal effect has not been explored. It should be highlighted that this study aims to explore the potential beneficial role of fresh grapes, consumed as fruit; in order to ensure the stability of the product, they will be provided as freeze-dried milled material, but the amount received by the subjects could be incorporated into a common diet, being equivalent to 300 g of fresh grapes.
Detailed description
Twenty-five subjects with obesity will be were recruited. Detailed inclusion and exclusion criteria are provided below.
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. Both interventions will be separated by two weeks. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, viscosity, antioxidant capacity. Additionally, a satiety test will be provided. It is expected that grape supplementation, as compared with an isocaloric placebo, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the area under the curve for glucose after the second meal (300-420 min from basal time).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- GRAP: dried and milled grape pomaces. PLA: control period. All the subjects will pass the two periods: one half will receive the acute PLA supplementation followed by the acute GRAP supplementation, and the other half will do it inversely. The assignment to each order will be done randomly. Both period will be separated by a two weeks washing period.
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Freeze-dried grape (GRAP)/Placebo (PLA)All subjects will receive a high-fat breakfast and a medium-fat lunch twice. They will consume together with the breakfast the placebo (PLA) the first time and grape (GRAP) the second time. |
| 2 | Experimental | Other: Freeze-dried grape (GRAP)/Placebo (PLA)All subjects will receive a high-fat breakfast and a medium-fat lunch twice. They will consume together with the breakfast grape (GRAP) the first time and the placebo (PLA) the second time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obesity (BMI = 30-40 kg/m2).
Key exclusion criteria (7 listed)
- Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- Subjects with diagnoses of type 2 diabetes, cardiovascular diseases or thyroid diseases.
- Values above the following ones: glucose, > 115 mg/dL; triglycerides, > 350 mg/dL; total cholesterol, > 280 mg/dL; systolic blood pressure, > 150 mmHg; diastolic blood pressure, > 100 mmHg
- Previous bariatric surgery.
- Volunteers participating in other studies (currently or during last year) or weight loss plans.
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 |
|---|---|---|
| Freeze-dried grape (GRAP)/Placebo (PLA)The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. A total of 10 samples will be collected: 0-30-60-120-180-240-300-330-360-420 min. Both interventions will be separated by two weeks. Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided). | Other | 1, 2 |
Primary outcome
Postprandial glucose (300-420 min)
Time frame: Up to two months
Changes of postprandial blood glucose as result of supplementation with grapes, measured area under the curve for the period 300-420 min
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 25 Feb 2020.
- Derived from this study: PubMed 33386890Garcia-Diez E, Cuesta-Hervas M, Veses-Alcobendas AM, Alonso-Gordo O, Garcia-Maldonado E, Martinez-Suarez M, Herranz B, Vaquero MP, Alvarez MD, Perez-Jimenez J. Acute supplementation with grapes in obese subjects did not affect postprandial metabolism: a randomized, double-blind, crossover clinical trial. Eur J Nutr. 2021 Aug;60(5):2671-2681. doi: 10.1007/s00394-020-02451-6. Epub 2021 Jan 2.
- Individual participant dataSharing planned: No
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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.
Jara Pérez-Jiménez, PhD principal investigator
Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity, 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 1 inclusion and 7 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 25 Feb 2020. 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?
Postprandial glucose (300-420 min) (time frame: Up to two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741218, which also lists 1 linked publication.
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 25 Feb 2020.