Clinical trial NCT05977543: Acute Effect of Functional Crackers on Postprandial Metabolism
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: enriched with 10% grape seed flour crackers
40% barley flour crackers enriched with β-glucan
postprandial effect
Lead sponsor: University of the Aegean
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Glucose
timeFrame: 3 hours
measure: Total Antioxidant Capacity
timeFrame: 3 hours
Secondary outcomes:
measure: Total cholesterol
timeFrame: 3 hours
measure: High Density Lipoprotein cholesterol
timeFrame: 3 hours
measure: Low Density Lipoprotein cholesterol
timeFrame: 3 hours
measure: Triglycerides
timeFrame: 3 hours
measure: Uric Acid
timeFrame: 3 hours
Other outcomes:
Locations:
city: Myrina
country: Greece
facility: University of the Aegean
state: Limnos/Lesvos
Study officials:
affiliation: University of the Aegean
name: Antonios Koutelidakis, Professor
role: STUDY_DIRECTOR
References: