Metabolic Effects of High-amylose Wheat-based Rusks.

NCT ID: NCT02702934

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-02-29

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.

Conditions

Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

High-amylose rusks

Test meal with 100g of carbohydrates coming from high-amylose rusks

Group Type: EXPERIMENTAL

Test meal

Intervention Type: OTHER

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.

Control rusks

Test meal with 100g of carbohydrates coming from regular rusks used as control

Group Type: ACTIVE_COMPARATOR

Test meal

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Acute test meal

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

rivellese angela

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Rivellese, Professor

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

Department of Clinical Medicine and Surgery

Naples, , Italy

Countries

Italy

Other Identifiers

233/14

Identifier Type: -

Identifier Source: org_study_id