Crade23: Acute Effect of Functional Crackers on Postprandial Metabolism

Sponsor

University of the Aegean (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05977543

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Functional crackers enriched with grape seed flour Other: Functional crackers with 40% barley flour and enriched with β-glucans	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

On enrolment, all subjects were randomly assigned to the C: F1:F2 group (Control: Functional 1: Functional 2), to the F1: C: F2 group (Functional 1: Control: Functional 2) or to the F2: F1: C group (Functional 2: Functional 1: Control). Subjects in the C: F1:F2 group received the Control meal on the first visit, the Functional meal 1 on the second visit and the Functional meal 2 on the third visit; those in the F1:C:F2 group received the Functional meal 1 on the first visit, the Control meal on the second visit and the Functional meal 2 on the third visit while those in the F2:F1:C group received the Functional meal 2 on the first visit, the meal Functional meal 1 on the second visit and the Control meal on the third visit.On enrolment, all subjects were randomly assigned to the C: F1:F2 group (Control: Functional 1: Functional 2), to the F1: C: F2 group (Functional 1: Control: Functional 2) or to the F2: F1: C group (Functional 2: Functional 1: Control). Subjects in the C: F1:F2 group received the Control meal on the first visit, the Functional meal 1 on the second visit and the Functional meal 2 on the third visit; those in the F1:C:F2 group received the Functional meal 1 on the first visit, the Control meal on the second visit and the Functional meal 2 on the third visit while those in the F2:F1:C group received the Functional meal 2 on the first visit, the meal Functional meal 1 on the second visit and the Control meal on the third visit.

Masking:

Single (Participant)

Masking Description:

Only investigators knew the group in which each participant were enrolled.

Primary Purpose:

Other

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

Actual Study Start Date :

Feb 15, 2023

Actual Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Oct 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control wheat crackers Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers.
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

Arm

Intervention/Treatment

No Intervention: Control wheat crackers

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

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

Outcome Measures

Primary Outcome Measures

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

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
Triglycerides [3 hours]
Triglycerides concentration changes from baseline at 3hours
Uric Acid [3 hours]
Uric Acid concentration changes from baseline at 3hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of the Aegean	Myrina	Limnos/Lesvos	Greece	81 400

Sponsors and Collaborators

University of the Aegean

Investigators

Study Director: Antonios Koutelidakis, Professor, University of the Aegean

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of the Aegean

ClinicalTrials.gov Identifier:

NCT05977543

Other Study ID Numbers:

12123

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 8, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of the Aegean

enriched with 10% grape seed flour crackers

40% barley flour crackers enriched with β-glucan

postprandial effect

Study Results

No Results Posted as of Aug 8, 2023