Acute Effect of Functional Crackers on Postprandial Metabolism

Study Overview
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Other: Functional crackers enriched with grape seed flour
* Other: Functional crackers with 40% barley flour and enriched with β-glucans


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control wheat crackers<br>Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers. | |
| Other: Grape seed flour crackers<br>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<br>* The crackers was enriched with 10% grape seed flour<br>* Other names: Grape seed flour crackers;|
| Other: Barley flour and β-glucan crackers<br>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<br>* The crackers consisted of 60% wheat flour, 40% barley flour and was enriched with β-glucans.<br>* Other names: Barley flour crackers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Total cholesterol concentration changes from baseline at 3hours | 3 hours | 
| High Density Lipoprotein cholesterol | High Density Lipoprotein concentration cholesterol changes from baseline at 3hours | 3 hours | 
| Low Density Lipoprotein cholesterol | Low Density Lipoprotein cholesterol concentration changes from baseline at 3hours | 3 hours | 
| Triglycerides | Triglycerides concentration changes from baseline at 3hours | 3 hours | 
| Uric Acid | Uric Acid concentration changes from baseline at 3hours | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enriched with 10% grape seed flour crackers, 40% barley flour crackers enriched with β-glucan, postprandial effect