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Completed

NCT Number: NCT03899974

Metabolic Effects of High-amylose Wheat-based Breads

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.

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Key information

Conditions

Postprandial Hyperglycemia Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Test meal

Other

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 outcomes

  1. 2-hours blood glucose response

    Time frame: over 2 hours after the test meal

    incremental area under the curve

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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