Metabolic Effects of High-amylose Wheat-based Breads

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

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Hyperglycemia
• Intervention / Treatment: Other: Test meal

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples
    • Napoli, Naples, Italy, 80131
      • Federico II University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 252/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No