Back to resultsMetabolic Effects of High-amylose Wheat-based Rusks.
Primary Purpose
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 Hyperglycemia
Eligibility 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.
Sites / Locations
- Department of Clinical Medicine and Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-amylose rusks
Control rusks
Arm Description
Test meal with 100g of carbohydrates coming from high-amylose rusks
Test meal with 100g of carbohydrates coming from regular rusks used as control
Outcomes
Primary Outcome Measures
Blood glucose
Incremental area under the curve
Secondary Outcome Measures
Blood insulin
Incremental area under the curve
Intestinal fermentation
Incremental area under the curve
Blood triglycerides
Incremental area under the curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02702934
Brief Title
Metabolic Effects of High-amylose Wheat-based Rusks.
Official Title
Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-amylose rusks
Arm Type
Experimental
Arm Description
Test meal with 100g of carbohydrates coming from high-amylose rusks
Arm Title
Control rusks
Arm Type
Active Comparator
Arm Description
Test meal with 100g of carbohydrates coming from regular rusks used as control
Intervention Type
Other
Intervention Name(s)
Test meal
Other Intervention Name(s)
Acute test meal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood glucose
Description
Incremental area under the curve
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Blood insulin
Description
Incremental area under the curve
Time Frame
4 hours
Title
Intestinal fermentation
Description
Incremental area under the curve
Time Frame
4 hours
Title
Blood triglycerides
Description
Incremental area under the curve
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Rivellese, Professor
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Medicine and Surgery
City
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 Rusks.
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