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NCT Number: NCT02702934

Metabolic Effects of High-amylose Wheat-based Rusks.

Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Medicine and Surgery

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;
  • 30-60 years.

Exclusion criteria

  • age <30 and >60 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);
  • any chronic disease.

Treatment and study plan

Test meal

Other

Participants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour 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.

Other names: Acute test meal

Primary outcomes

  1. Blood glucose

    Time frame: 4 hours

    Incremental area under the curve

Secondary outcomes

  1. Blood insulin

    Time frame: 4 hours

    Incremental area under the curve

  2. Intestinal fermentation

    Time frame: 4 hours

    Incremental area under the curve

  3. Blood triglycerides

    Time frame: 4 hours

    Incremental area under the curve

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Aug 10, 2017

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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