Metabolic Effects of High-amylose Wheat-based Breads

Not Applicable

Completed

• Conditions: Postprandial Hyperglycemia
• Interventions: Other: Test meal

• Registration Number: NCT03899974
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-12-15
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Study Completion: 2019-07-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control bread	Test meal	Mixed meal with 80g of available carbohydrates coming mainly from conventional bread
70% amylose bread	Test meal	Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour)
85% amylose bread	Test meal	Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour)

Primary Outcome Measures

Name	Time	Method
2-hours blood glucose response	over 2 hours after the test meal	incremental area under the curve

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Napoli, Naples, Italy