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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of the Aegean
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Total Antioxidant Capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Only investigators knew the group in which each participant were enrolled.
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- 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)
Arms & Interventions
Control wheat crackers
Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers.
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.
Intervention: Functional crackers enriched with grape seed flour (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
Intervention: Functional crackers with 40% barley flour and enriched with β-glucans (Other)
Outcomes
Primary Outcomes
Total Antioxidant Capacity
Time Frame: 3 hours
Total Antioxidant Capacity concentration changes from baseline at 3 hours
Glucose
Time Frame: 3 hours
Glucose concentration changes from baseline at 3hours
Secondary Outcomes
- High Density Lipoprotein cholesterol(3 hours)
- Low Density Lipoprotein cholesterol(3 hours)
- Total cholesterol(3 hours)
- Triglycerides(3 hours)
- Uric Acid(3 hours)