Acute Effect of Functional Crackers on Postprandial Metabolism

Not Applicable

Active, not recruiting

• Conditions: Healthy

• 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

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

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