A Mild Supplementation of Arabinoxylan Fiber Improves Homa Index in Overweight and Obese Subjects.

Not Applicable

• Conditions: Nutritional and Metabolic Diseases

• Registration Number: NCT02847351
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

The study aimed to investigate whether an Arabinoxylan-enriched crackers consumption for 4 weeks in overweight and obese patients without diabetes mellitus have specific healthy effects on glycemic control (reduction of homeostatic model assessment -HOMA index-). Furthermore, study evaluated the effects of Arabinoxylan on insulin, lipid and Ghrelin.

Detailed Description

The beneficial effects of soluble dietary fiber to health are well known: many studies show clearly that it delays the onset of cardiovascular disease and some cancers, and improves glycemic control in type 2 diabetes. (1,2). Overweight and obesity are known to be associated with increased rate of diabetes, hypertension and cardiovascular diseases, as well as to colon and breast cancer. The introduction of 25-30gr of dietary fiber daily would therefore indicated not only in type 2 diabetic subjects, but also in obese and overweight patients. Most of the foods commonly consumed in Western countries are low in dietary fiber: to reach the recommended levels people should introduce whole grain cereals, legumes, vegetables and dried fruits, not always accepted. We tested the effects on health of crackers baked with a special Integralbianco® flour, enriched with 3,2g of Arabinoxylan / 100g (vs refined flour).

Study Timeline

• Study Start: 2014-07
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• males and females
• age ≥ 18 years
• Body mass Index ≥ 27

Exclusion Criteria

• diabetes mellitus
• already established organ damage
• debilitating diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reduction of Homa Index after Ax Diet vs CD Diet	4 weeks of arabinoxylan dietetic supplementation	The study aimed to investigate whether an Arabinoxylan enriched crackers consumption for 4 weeks in overweight or obese patients without diabetes mellitus have specific healthy effects on glycemic control, evaluated as reduction of Homa Index.

Secondary Outcome Measures

Name	Time	Method
Improvement of lipidic profile after AxDiet vs CD Diet	4 weeks of arabinoxylan dietetic supplementation	The study aimed to investigate whether an Arabinoxylan enriched crackers consumption for 4 weeks had some benefic effects on lipids.
Improvement of weight after AxDiet vs CD Diet	4 weeks of arabinoxylan dietetic supplementation	We investigate whether an Arabinoxylan enriched crackers consumption for 4 weeks had some effects on weight loss in obese or overweight subjects.

Trial Locations

Locations (2)

Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation; 🇮🇹 Pavia, PV, Italy

IRCCS Policlinico San Matteo Foundation; 🇮🇹 Pavia, Italy