Acute Effect of Functional Crackers on Postprandial Metabolism

Not Applicable

Active, not recruiting

• Conditions: Healthy
• Interventions: Other: Functional crackers enriched with grape seed flour; Other: Functional crackers with 40% barley flour and enriched with β-glucans

• Registration Number: NCT05977543
• Lead Sponsor: University of the Aegean

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-02-15
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-04
• Primary Completion: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Age 19-65 years

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Grape seed flour crackers	Functional crackers enriched with grape seed flour	Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers, enriched with 10% grape seed flour crackers.
Barley flour and β-glucan crackers	Functional crackers with 40% barley flour and enriched with β-glucans	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

Primary Outcome Measures

Name	Time	Method
Glucose	3 hours	Glucose concentration changes from baseline at 3hours
Total Antioxidant Capacity	3 hours	Total Antioxidant Capacity concentration changes from baseline at 3 hours

Secondary Outcome Measures

Name	Time	Method
Triglycerides	3 hours	Triglycerides concentration changes from baseline at 3hours
Uric Acid	3 hours	Uric Acid concentration changes from baseline at 3hours
Total cholesterol	3 hours	Total cholesterol concentration changes from baseline at 3hours
High Density Lipoprotein cholesterol	3 hours	High Density Lipoprotein concentration cholesterol changes from baseline at 3hours
Low Density Lipoprotein cholesterol	3 hours	Low Density Lipoprotein cholesterol concentration changes from baseline at 3hours

Trial Locations

Locations (1)

University of the Aegean; 🇬🇷 Myrina, Limnos/Lesvos, Greece