Acute Effect of Functional Crackers on Postprandial Metabolism

NCT05977543 | Unknown

• 1 other identifier: 12123
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Total cholesterol

  3 hours

• High Density Lipoprotein cholesterol

  3 hours

• Low Density Lipoprotein cholesterol

  3 hours

• Triglycerides

  3 hours

• Uric Acid

  3 hours

Study Arms (3)

Control wheat crackers

NO INTERVENTION

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

Grape seed flour crackers

OTHER

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

Barley flour and β-glucan crackers

OTHER

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

Interventions

Functional crackers enriched with grape seed flour OTHER

The crackers was enriched with 10% grape seed flour

Also known as: Grape seed flour crackers

Grape seed flour crackers

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

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

Also known as: Barley flour crackers

Barley flour and β-glucan crackers

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-65 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of the Aegean: lead

Study Sites (1)

University of the Aegean

Myrina, Limnos/Lesvos, 81 400, Greece

Location

Study Officials

• Antonios Koutelidakis, Professor

  University of the Aegean

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only investigators knew the group in which each participant were enrolled.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 4, 2023
• Study Start: February 15, 2023
• Primary Completion: October 1, 2023
• Study Completion: January 15, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)