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Acute Effect of Functional Crackers on Postprandial Metabolism

NCT ID: NCT05977543

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-01-15

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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enriched with 10% grape seed flour crackers 40% barley flour crackers enriched with β-glucan postprandial effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

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

Study Groups

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Control wheat crackers

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

Functional crackers enriched with grape seed flour

Intervention Type OTHER

The crackers was enriched with 10% grape seed flour

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

Group Type OTHER

Functional crackers with 40% barley flour and enriched with β-glucans

Intervention Type OTHER

The crackers consisted of 60% wheat flour, 40% barley flour and was enriched with β-glucans.

Interventions

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Functional crackers enriched with grape seed flour

The crackers was enriched with 10% grape seed flour

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Grape seed flour crackers Barley flour crackers

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the Aegean

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonios Koutelidakis, Professor

Role: STUDY_DIRECTOR

University of the Aegean

Locations

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University of the Aegean

Myrina, Limnos/Lesvos, Greece

Site Status

Countries

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Greece

Other Identifiers

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12123

Identifier Type: -

Identifier Source: org_study_id