Acute Effect of Functional Crackers on Postprandial Metabolism

Healthy Clinical Trial

— Crade23  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05977543
• Other study ID #: 12123
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: November 2023
• Source: University of the Aegean
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: January 15, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Functional crackers enriched with grape seed flour
The crackers was enriched with 10% grape seed flour
• Functional crackers with 40% barley flour and enriched with ß-glucans
The crackers consisted of 60% wheat flour, 40% barley flour and was enriched with ß-glucans.

Locations

Country	Name	City	State
Greece	University of the Aegean	Myrina	Limnos/Lesvos

Sponsors (1)

Lead Sponsor	Collaborator
University of the Aegean

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	Glucose concentration changes from baseline at 3hours	3 hours
Primary	Total Antioxidant Capacity	Total Antioxidant Capacity concentration changes from baseline at 3 hours	3 hours
Secondary	Total cholesterol	Total cholesterol concentration changes from baseline at 3hours	3 hours
Secondary	High Density Lipoprotein cholesterol	High Density Lipoprotein concentration cholesterol changes from baseline at 3hours	3 hours
Secondary	Low Density Lipoprotein cholesterol	Low Density Lipoprotein cholesterol concentration changes from baseline at 3hours	3 hours
Secondary	Triglycerides	Triglycerides concentration changes from baseline at 3hours	3 hours
Secondary	Uric Acid	Uric Acid concentration changes from baseline at 3hours	3 hours