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

NCT02847351 | Unknown

• 1 other identifier: 30200/9334
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Nutritional and Metabolic Diseases

Keywords

arabinoxylan, HOMA index, glycemic control, obesity.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improvement of lipidic profile after AxDiet vs CD Diet

  4 weeks of arabinoxylan dietetic supplementation

• Improvement of weight after AxDiet vs CD Diet

  4 weeks of arabinoxylan dietetic supplementation

Study Arms (2)

Control Diet (CD)

PLACEBO COMPARATOR

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

Arabinoxylan Diet (AXD)

EXPERIMENTAL

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

Interventions

Arabinoxylan Diet DIETARY_SUPPLEMENT

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).

Also known as: Integralbianco® flour- Farine Varvello

Arabinoxylan Diet (AXD); Control Diet (CD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• diabetes mellitus
• already established organ damage
• debilitating diseases

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (2)

IRCCS Policlinico San Matteo Foundation

Pavia, Pavia, 27100, Italy

Location

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

Pavia, PV, 27100, Italy

Location

Related 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: 10.3109/19390211.2016.1156798. Epub 2016 Apr 6.

  PMID: 27049812 RESULT

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chiara Muggia, Medicine

  IRCCS Policlinico San Matteo Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)