Metabolic Effects of High-amylose Wheat-based Rusks.

Study Overview
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Brief Summary
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Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.

Official Title
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Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.

Conditions
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Hyperglycemia

Intervention / Treatment
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* Other: Test meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight/obese; 30-60 years. Exclusion Criteria: age <30 and >60 years; fasting triglycerides ≥400 mg/dl; fasting cholesterol >270 mg/dl; cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study; established diabetes mellitus or any chronic disease; renal and liver failure (creatinine >1.7 mg/dl and transaminases >2 times than normal values, respectively); anaemia (Hb <12 g /dl); any chronic disease.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-amylose rusks<br>Test meal with 100g of carbohydrates coming from high-amylose rusks | Other: Test meal<br>* Participants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations.<br>* Other names: Acute test meal;|
| Active Comparator: Control rusks<br>Test meal with 100g of carbohydrates coming from regular rusks used as control | Other: Test meal<br>* Participants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations.<br>* Other names: Acute test meal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Incremental area under the curve | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood insulin | Incremental area under the curve | 4 hours | 
| Intestinal fermentation | Incremental area under the curve | 4 hours | 
| Blood triglycerides | Incremental area under the curve | 4 hours |