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

Primary Purpose

Nutritional and Metabolic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Arabinoxylan Diet
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional and Metabolic Diseases focused on measuring arabinoxylan, HOMA index, glycemic control, obesity.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes mellitus
  • already established organ damage
  • debilitating diseases

Sites / Locations

  • Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation
  • IRCCS Policlinico San Matteo Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Diet (CD)

Arabinoxylan Diet (AXD)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 25, 2016
Last Updated
July 25, 2016
Sponsor
IRCCS Policlinico S. Matteo
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1. Study Identification

Unique Protocol Identification Number
NCT02847351
Brief Title
A Mild Supplementation of Arabinoxylan Fiber Improves Homa Index in Overweight and Obese Subjects.
Official Title
A Mild Supplementation of Arabinoxylan Fiber Improves Homa Index in Overweight and Obese Subjects. Results From a Randomized Cross Over Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional and Metabolic Diseases
Keywords
arabinoxylan, HOMA index, glycemic control, obesity.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Diet (CD)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Arabinoxylan Diet (AXD)
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Arabinoxylan Diet
Other Intervention Name(s)
Integralbianco® flour- Farine Varvello
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction of Homa Index after Ax Diet vs CD Diet
Description
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.
Time Frame
4 weeks of arabinoxylan dietetic supplementation
Secondary Outcome Measure Information:
Title
Improvement of lipidic profile after AxDiet vs CD Diet
Description
The study aimed to investigate whether an Arabinoxylan enriched crackers consumption for 4 weeks had some benefic effects on lipids.
Time Frame
4 weeks of arabinoxylan dietetic supplementation
Title
Improvement of weight after AxDiet vs CD Diet
Description
We investigate whether an Arabinoxylan enriched crackers consumption for 4 weeks had some effects on weight loss in obese or overweight subjects.
Time Frame
4 weeks of arabinoxylan dietetic supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: males and females age ≥ 18 years Body mass Index ≥ 27 Exclusion Criteria: diabetes mellitus already established organ damage debilitating diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiara Muggia, Medicine
Organizational Affiliation
IRCCS Policlinico San Matteo Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS Policlinico San Matteo Foundation
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27049812
Citation
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.
Results Reference
result

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

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