Clinical trial NCT02847351: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Nutritional and Metabolic Diseases
Keywords: arabinoxylan, HOMA index, glycemic control, obesity.
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* diabetes mellitus
* already established organ damage
* debilitating diseases

Primary outcomes:
measure: Reduction of Homa Index after Ax Diet vs CD Diet
timeFrame: 4 weeks of arabinoxylan dietetic supplementation
Secondary outcomes:
measure: Improvement of lipidic profile after AxDiet vs CD Diet
timeFrame: 4 weeks of arabinoxylan dietetic supplementation
measure: Improvement of weight after AxDiet vs CD Diet
timeFrame: 4 weeks of arabinoxylan dietetic supplementation
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation
state: PV
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo Foundation
Study officials:
affiliation: IRCCS Policlinico San Matteo Foundation
name: Chiara Muggia, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
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.