Metabolic Effects of High-amylose Wheat-based Breads
Primary Purpose
Postprandial Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Test meal
Sponsored by
About this trial
This is an interventional prevention trial for Postprandial Hyperglycemia
Eligibility Criteria
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)
Sites / Locations
- Federico II University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
70% amylose bread
85% amylose bread
Control bread
Arm Description
Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour)
Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour)
Mixed meal with 80g of available carbohydrates coming mainly from conventional bread
Outcomes
Primary Outcome Measures
2-hours blood glucose response
incremental area under the curve
Secondary Outcome Measures
2-hours blood insulin response
incremental area under the curve
4-hours blood glucose response
incremental area under the curve
4-hours blood insulin response
incremental area under the curve
intestinal fermentation
breath test for the detection of hydrogen production
glucose response
Second meal effect
Full Information
NCT ID
NCT03899974
First Posted
March 29, 2019
Last Updated
December 3, 2019
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT03899974
Brief Title
Metabolic Effects of High-amylose Wheat-based Breads
Official Title
Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
70% amylose bread
Arm Type
Experimental
Arm Description
Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour)
Arm Title
85% amylose bread
Arm Type
Experimental
Arm Description
Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour)
Arm Title
Control bread
Arm Type
Active Comparator
Arm Description
Mixed meal with 80g of available carbohydrates coming mainly from conventional bread
Intervention Type
Other
Intervention Name(s)
Test meal
Intervention Description
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 Outcome Measure Information:
Title
2-hours blood glucose response
Description
incremental area under the curve
Time Frame
over 2 hours after the test meal
Secondary Outcome Measure Information:
Title
2-hours blood insulin response
Description
incremental area under the curve
Time Frame
over 2 hours after the test meal
Title
4-hours blood glucose response
Description
incremental area under the curve
Time Frame
over 4 hours after the test meal
Title
4-hours blood insulin response
Description
incremental area under the curve
Time Frame
over 4 hours after the test meal
Title
intestinal fermentation
Description
breath test for the detection of hydrogen production
Time Frame
over 4 hours after the test meal
Title
glucose response
Description
Second meal effect
Time Frame
over 2 hours after the standard meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Federico II University
City
Napoli
State/Province
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Metabolic Effects of High-amylose Wheat-based Breads
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