Healthy
Conditions
Keywords
enriched with 10% grape seed flour crackers, 40% barley flour crackers enriched with β-glucan, postprandial effect
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.
Interventions
OTHERFunctional crackers enriched with grape seed flour
The crackers was enriched with 10% grape seed flour
OTHERFunctional 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.
Sponsors
University of the Aegean
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Only investigators knew the group in which each participant were enrolled.
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Greece
Outcome results
None listed