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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Nutritional and Metabolic Diseases

Intervention / Treatment
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* Dietary Supplement: Arabinoxylan Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males and females age ≥ 18 years Body mass Index ≥ 27 Exclusion Criteria: diabetes mellitus already established organ damage debilitating diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Diet (CD)<br>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<br>* 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).<br>* Other names: Integralbianco® flour- Farine Varvello;|
| Experimental: Arabinoxylan Diet (AXD)<br>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<br>* 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).<br>* Other names: Integralbianco® flour- Farine Varvello;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arabinoxylan, HOMA index, glycemic control, obesity.