Viewing Study NCT02847351


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Study NCT ID: NCT02847351
Status: UNKNOWN
Last Update Posted: 2016-07-28
First Post: 2016-07-25
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: A Mild Supplementation of Arabinoxylan Fiber Improves Homa Index in Overweight and Obese Subjects.
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:

Study Overview

Official Title: A Mild Supplementation of Arabinoxylan Fiber Improves Homa Index in Overweight and Obese Subjects. Results From a Randomized Cross Over Trial.
Status: UNKNOWN
Status Verified Date: 2016-07
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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).

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: