Metabolic Effects of High-amylose Wheat-based Rusks.

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia
• Intervention / Treatment: Other: Test meal

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Department of Clinical Medicine and Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Acute test meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose	Incremental area under the curve	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood insulin	Incremental area under the curve	4 hours
Intestinal fermentation	Incremental area under the curve	4 hours
Blood triglycerides	Incremental area under the curve	4 hours

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Angela Rivellese, Professor, Federico II University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 233/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO