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

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

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.

Study Overview

• Status: Unknown
• Conditions: Nutritional and Metabolic Diseases
• Intervention / Treatment: Dietary supplement: Arabinoxylan Diet

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 Type: Interventional
• Enrollment (Anticipated): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • irccs policlinico san matteo foundation
  • PV
    • Pavia, PV, Italy, 27100
      • Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• diabetes mellitus
• already established organ damage
• debilitating diseases

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Diet (CD); Period 1(the first 4 weeks): 10 subjects were randomly assigned to Control Diet: they replaced for 4 weeks all the carbohydrates consumed in day (bread, pasta, runks) with crackers produced with a normal white grain flour. After this period they crossed to period 2 (the second 4 weeks of treatment) without any wash out: they replaced for 4 weeks all the carbohydrates consumed in day (bread, pasta, runks) with crackers produced with Arabinoxylan-enriched flour.	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).; Other Names: Integralbianco® flour- Farine Varvello
Experimental: Arabinoxylan Diet (AXD); Period 1(the first 4 weeks): 9 subjects were randomly assigned to Arabinoxylan-Diet: they replaced for 4 weeks all the carbohydrates consumed in day with crackers baked with an Arabinoxylan-enriched flour. After this period they crossed to period 2 (the second 4 weeks of treatment) without any wash out: they replaced for 4 weeks all the carbohydrates consumed in day with crackers produced with a normal white grain flour	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).; Other Names: Integralbianco® flour- Farine Varvello

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Chiara Muggia, Medicine, irccs policlinico san matteo foundation

Publications and helpful links

General Publications

• 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: 10.3109/19390211.2016.1156798. Epub 2016 Apr 6.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: arabinoxylan, HOMA index, glycemic control, obesity.
• Additional Relevant MeSH Terms: Body Weight; Overweight; Metabolic Diseases
• Other Study ID Numbers: 30200/9334

Plan for Individual participant data (IPD)

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