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Metabolic Effects of High-amylose Wheat-based Breads

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ClinicalTrials.gov Identifier: NCT03899974
Recruitment Status : Active, not recruiting
First Posted : April 2, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postprandial Hyperglycemia Other: Test meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : December 15, 2018
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: 70% amylose bread
Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour)
Other: Test meal

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.


Experimental: 85% amylose bread
Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour)
Other: Test meal

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.


Active Comparator: Control bread
Mixed meal with 80g of available carbohydrates coming mainly from conventional bread
Other: Test meal

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.





Primary Outcome Measures :
  1. 2-hours blood glucose response [ Time Frame: over 2 hours after the test meal ]
    incremental area under the curve


Secondary Outcome Measures :
  1. 2-hours blood insulin response [ Time Frame: over 2 hours after the test meal ]
    incremental area under the curve

  2. 4-hours blood glucose response [ Time Frame: over 4 hours after the test meal ]
    incremental area under the curve

  3. 4-hours blood insulin response [ Time Frame: over 4 hours after the test meal ]
    incremental area under the curve

  4. intestinal fermentation [ Time Frame: over 4 hours after the test meal ]
    breath test for the detection of hydrogen production

  5. glucose response [ Time Frame: over 2 hours after the standard meal ]
    Second meal effect



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899974


Locations
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Italy
Federico II University
Napoli, Naples, Italy, 80131
Sponsors and Collaborators
Federico II University

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Responsible Party: rivellese angela, Full Professor, Federico II University
ClinicalTrials.gov Identifier: NCT03899974     History of Changes
Other Study ID Numbers: 252/17
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases