Grape Polyphenols and Second-meal Effect

NCT03741218 | Completed

• 1 other identifier: HRG_2018
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Polyphenols; Obesity; Grape; Postprandial; Insulin resistance; Second meal effect

Outcome Measures

Primary Outcomes (1)

• 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

  Up to two months

Other Outcomes (6)

• Postprandial glucose and insulin

  Up to four months

• Plasma triglycerides

  Up to four months

• Plasma uric acid

  Up to four months

Study Arms (2)

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.

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.

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

Interventions

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).

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obesity (BMI = 30-40 kg/m2).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Council, Spain: lead
• California Table Grape Commission: collaborator

Study Sites (1)

Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 33386890 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Jara Pérez-Jiménez, PhD

  Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: GRAP and PLA will have the same aspect, so neither the participant and the care provider will know the received treatment at each stage.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 14, 2018
• Study Start: December 10, 2018
• Primary Completion: November 1, 2019
• Study Completion: February 15, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)