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

NCT ID: NCT02847351

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-31

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).

Conditions

Nutritional and Metabolic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Arabinoxylan Diet

Intervention Type: 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).

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

Group Type: EXPERIMENTAL

Arabinoxylan Diet

Intervention Type: 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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Integralbianco® flour- Farine Varvello

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• diabetes mellitus
• already established organ damage
• debilitating diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Chiara Muggia; MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chiara Muggia, Medicine

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico San Matteo Foundation

Locations

IRCCS Policlinico San Matteo Foundation

Pavia, Pavia, Italy

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

Pavia, PV, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 27049812 (View on PubMed)

Other Identifiers

30200/9334

Identifier Type: -

Identifier Source: org_study_id