Grape Polyphenols and Second-meal Effect (GRAPESECOND)

Higher Council for Scientific Research (CSIC)

Status: Completed

Conditions: Obesity

Treatments: Other: Freeze-dried grape (GRAP)/Placebo (PLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03741218

HRG_2018

Details and patient eligibility

About

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.

Full 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).

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obesity (BMI = 30-40 kg/m2).

Exclusion criteria

• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Other: Freeze-dried grape (GRAP)/Placebo (PLA)

2

Experimental group

Description:

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.

Treatment:

Other: Freeze-dried grape (GRAP)/Placebo (PLA)