Metabolic Effects of High-amylose Wheat-based Breads

Postprandial Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899974
• Other study ID #: 252/17
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2019
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
Italy	Federico II University	Napoli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-hours blood glucose response	incremental area under the curve	over 2 hours after the test meal
Secondary	2-hours blood insulin response	incremental area under the curve	over 2 hours after the test meal
Secondary	4-hours blood glucose response	incremental area under the curve	over 4 hours after the test meal
Secondary	4-hours blood insulin response	incremental area under the curve	over 4 hours after the test meal
Secondary	intestinal fermentation	breath test for the detection of hydrogen production	over 4 hours after the test meal
Secondary	glucose response	Second meal effect	over 2 hours after the standard meal