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

Nutritional and Metabolic Diseases Clinical Trial

Official title:

A Mild Supplementation of Arabinoxylan Fiber Improves Homa Index in Overweight and Obese Subjects. Results From a Randomized Cross Over Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02847351
• Other study ID #: 30200/9334
• Status: Active, not recruiting
• Phase: N/A
• First received: July 25, 2016
• Last updated: July 25, 2016
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• males and females

• age = 18 years

• Body mass Index = 27

Exclusion Criteria:

• diabetes mellitus

• already established organ damage

• debilitating diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Overweight

Intervention

Dietary Supplement:
• Arabinoxylan Diet
19 free-living subjects (16 F/ 3M) attending from one year the Outpatient Obesity Clinic Policlinico S. Matteo were enrolled. All subjects were already reached weight loss and were in a sort of "weight steady state". Based on 7-day food diary, a nutritionist composed 19 isocaloric diets, replacing all consumed carbohydrates with normal or AX crackers. The mean carbohydrates intake was 189.5g, with total fiber 20.6g. In AX diet total fiber was 25.3g/day (20.6 plus 4.68g of AX). Height, weight, waist circumference were obtained at time 0, at week 4 and 8. At every time were collected blood samples for glucose, insulin, total cholesterol, HDL-chol., tryglicerides, plasma acyl and des-acyl ghrelin. Glucose and insulin were , also collected 2 h after a 75 g oral glucose tolerance test (OGTT).

Locations

Country	Name	City	State
Italy	Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation	Pavia	PV
Italy	IRCCS Policlinico San Matteo Foundation	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Giulia Falchi A, Grecchi I, Muggia C, Palladini G, Perlini S. Effects of a Bioavailable Arabinoxylan-enriched White Bread Flour on Postprandial Glucose Response in Normoglycemic Subjects. J Diet Suppl. 2016 Nov;13(6):626-33. doi: 10.3109/19390211.2016.115 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Homa Index after Ax Diet vs CD Diet	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.	4 weeks of arabinoxylan dietetic supplementation	No
Secondary	Improvement of lipidic profile after AxDiet vs CD Diet	The study aimed to investigate whether an Arabinoxylan enriched crackers consumption for 4 weeks had some benefic effects on lipids.	4 weeks of arabinoxylan dietetic supplementation	No
Secondary	Improvement of weight after AxDiet vs CD Diet	We investigate whether an Arabinoxylan enriched crackers consumption for 4 weeks had some effects on weight loss in obese or overweight subjects.	4 weeks of arabinoxylan dietetic supplementation	No