Metabolic Effects of High-amylose Wheat-based Rusks.

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702934
• Other study ID #: 233/14
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: August 9, 2017
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
Italy	Department of Clinical Medicine and Surgery	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	Incremental area under the curve	4 hours
Secondary	Blood insulin	Incremental area under the curve	4 hours
Secondary	Intestinal fermentation	Incremental area under the curve	4 hours
Secondary	Blood triglycerides	Incremental area under the curve	4 hours