Metabolic Effects of High-amylose Wheat-based Breads

Study Overview
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Brief Summary
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The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. So far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. This randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.

Official Title
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Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals

Conditions
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Postprandial 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 18-70 years Exclusion Criteria: age <18 and >70 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 70% amylose bread<br>Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour) | Other: Test meal<br>* Participants received in random order the three test meal (700Kcal, 80g available carbohydrates) containing breads prepared with amylose-rich wheat flours (70% or 85%) 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. After 4 hours, all participants consumed a standard lunch (700 kcal, 100 g available carbohydrates) identical on all the three experimental days to evaluate the second meal effect from breakfast to lunch.<br>|
| Experimental: 85% amylose bread<br>Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour) | Other: Test meal<br>* Participants received in random order the three test meal (700Kcal, 80g available carbohydrates) containing breads prepared with amylose-rich wheat flours (70% or 85%) 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. After 4 hours, all participants consumed a standard lunch (700 kcal, 100 g available carbohydrates) identical on all the three experimental days to evaluate the second meal effect from breakfast to lunch.<br>|
| Active Comparator: Control bread<br>Mixed meal with 80g of available carbohydrates coming mainly from conventional bread | Other: Test meal<br>* Participants received in random order the three test meal (700Kcal, 80g available carbohydrates) containing breads prepared with amylose-rich wheat flours (70% or 85%) 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. After 4 hours, all participants consumed a standard lunch (700 kcal, 100 g available carbohydrates) identical on all the three experimental days to evaluate the second meal effect from breakfast to lunch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hours blood glucose response | incremental area under the curve | over 2 hours after the test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hours blood insulin response | incremental area under the curve | over 2 hours after the test meal | 
| 4-hours blood glucose response | incremental area under the curve | over 4 hours after the test meal | 
| 4-hours blood insulin response | incremental area under the curve | over 4 hours after the test meal | 
| intestinal fermentation | breath test for the detection of hydrogen production | over 4 hours after the test meal | 
| glucose response | Second meal effect | over 2 hours after the standard meal |