Acute Effect of Functional Crackers on Postprandial Metabolism (Crade23)

University of the Aegean

Status: Active, not recruiting

Conditions: Healthy

Treatments: Other: Functional crackers enriched with grape seed flour; Other: Functional crackers with 40% barley flour and enriched with β-glucans

Study type: Interventional

Funder types: Other

Identifiers

NCT05977543

12123

Details and patient eligibility

About

The aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants.

Full description

A pilot cross-over, controlled, randomized and single-blinded, intervention-clinical trial was carried out, in twelve healthy men and women, aged nineteen to sixty-five years, after random allocation into the control, the grape and the barley interventional groups, received a high-fat and high-carbohydrate meal, containing wheat flour or wheat and 10% grape seed flour or wheat and 40% barley flour, enriched with β-glucan, crackers. Participants consumed the same meals, allocating in cross-over order, with 1 washout week after each trial period. Differences on the metabolism of postprandial serum total, High Density Lipoprotein (HDL-), Low Density Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as well as of plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power method, were determined between groups in fasting, thirty minutes, one and a half hour, and three hours after meal intake.

Enrollment: 13 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19-65 years

Exclusion criteria

• Age over 65 years old
• History of chronic illness including type I and II diabetes (hemoglobin A1c-HbA1c > 5%)
• Abnormal Body Mass Index (BMI) (>25 kg/m2)
• Alcohol overconsumption (>40 g alcohol/day)
• Abnormal hematological and biochemical profiles (cholesterol > 6.8 mM, triglycerides > 2.8 mM, glucose > 6.11 mM)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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13 participants in 3 patient groups

Control wheat crackers

No Intervention group

Description:

Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers.

Grape seed flour crackers

Other group

Description:

Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers, enriched with 10% grape seed flour crackers.

Treatment:

Other: Functional crackers enriched with grape seed flour

Barley flour and β-glucan crackers

Other group

Description:

Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of 60% wheat flour and 40% barley flour crackers, enriched with β-glucan

Treatment:

Other: Functional crackers with 40% barley flour and enriched with β-glucans