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Trial record 31 of 748 for:    Area Under Curve AND meal

Metabolic Effects of High-amylose Wheat-based Rusks.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02702934
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Other: Test meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Experimental: High-amylose rusks
Test meal with 100g of carbohydrates coming from high-amylose rusks
Other: Test meal
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 Name: Acute test meal

Active Comparator: Control rusks
Test meal with 100g of carbohydrates coming from regular rusks used as control
Other: Test meal
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 Name: Acute test meal




Primary Outcome Measures :
  1. Blood glucose [ Time Frame: 4 hours ]
    Incremental area under the curve


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702934


Locations
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Italy
Department of Clinical Medicine and Surgery
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Angela Rivellese, Professor Federico II University

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Responsible Party: rivellese angela, Professor, Federico II University
ClinicalTrials.gov Identifier: NCT02702934     History of Changes
Other Study ID Numbers: 233/14
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases