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Trial record 86 of 785 for:    Area Under Curve AND meal

Metabolic Effects of High-amylose Wheat-based Breads

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: NCT03899974
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date December 4, 2019
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
2-hours blood glucose response [ Time Frame: over 2 hours after the test meal ]
incremental area under the curve
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03899974 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • 2-hours blood insulin response [ Time Frame: over 2 hours after the test meal ]
    incremental area under the curve
  • 4-hours blood glucose response [ Time Frame: over 4 hours after the test meal ]
    incremental area under the curve
  • 4-hours blood insulin response [ Time Frame: over 4 hours after the test meal ]
    incremental area under the curve
  • intestinal fermentation [ Time Frame: over 4 hours after the test meal ]
    breath test for the detection of hydrogen production
  • glucose response [ Time Frame: over 2 hours after the standard meal ]
    Second meal effect
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Effects of High-amylose Wheat-based Breads
Official Title  ICMJE Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postprandial Hyperglycemia
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: 70% amylose bread
    Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour)
    Intervention: Other: Test meal
  • Experimental: 85% amylose bread
    Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour)
    Intervention: Other: Test meal
  • Active Comparator: Control bread
    Mixed meal with 80g of available carbohydrates coming mainly from conventional bread
    Intervention: Other: Test meal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date December 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03899974
Other Study ID Numbers  ICMJE 252/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party rivellese angela, Federico II University
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federico II University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP