Ignite Creation Date:
2024-05-06 @ 12:23 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03741218
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2018-11-13
Brief Title:
Grape Polyphenols and Second-meal Effect
Sponsor:
National Research Council Spain
Organization:
National Research Council Spain
Study Overview
Official Title:
Potential Modulatory Effect of Whole Grape on Second-meal Tolerance in Obese Subjects Role of Polyphenols
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRAPESECOND
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None