Acute Effect of Functional Crackers on Postprandial Metabolism (Crade23)

The Acute Effect of Functional Crackers, Enriched With Grape Seed Flour or With Barley Flour and β-glucans, on Postprandial Glycemic, Lipemic and Antioxidant Metabolism

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Functional crackers enriched with grape seed flour; Other: Functional crackers with 40% barley flour and enriched with β-glucans

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Limnos/Lesvos
    • Myrina, Limnos/Lesvos, Greece, 81 400
      • University of the Aegean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Grape seed flour crackers; Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers, enriched with 10% grape seed flour crackers.	Other: Functional crackers enriched with grape seed flour; The crackers was enriched with 10% grape seed flour; Other Names: Grape seed flour crackers
Other: Barley flour and β-glucan crackers; 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	Other: Functional crackers with 40% barley flour and enriched with β-glucans; The crackers consisted of 60% wheat flour, 40% barley flour and was enriched with β-glucans.; Other Names: Barley flour crackers
No Intervention: Control wheat crackers; Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	Glucose concentration changes from baseline at 3hours	3 hours
Total Antioxidant Capacity	Total Antioxidant Capacity concentration changes from baseline at 3 hours	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol	Total cholesterol concentration changes from baseline at 3hours	3 hours
High Density Lipoprotein cholesterol	High Density Lipoprotein concentration cholesterol changes from baseline at 3hours	3 hours
Low Density Lipoprotein cholesterol	Low Density Lipoprotein cholesterol concentration changes from baseline at 3hours	3 hours
Triglycerides	Triglycerides concentration changes from baseline at 3hours	3 hours
Uric Acid	Uric Acid concentration changes from baseline at 3hours	3 hours

Collaborators and Investigators

• Sponsor: University of the Aegean
• Investigators: Study Director: Antonios Koutelidakis, Professor, University of the Aegean

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Estimated): January 15, 2024

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: postprandial effect; enriched with 10% grape seed flour crackers; 40% barley flour crackers enriched with β-glucan
• Other Study ID Numbers: 12123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share individual participant data for this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No