In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Adults)

Fugeia

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: placebo

Dietary Supplement: wheat bran extract

Study type

Interventional

Funder types

Industry

Identifiers

NCT01002651

ML5282

Details and patient eligibility

About

The investigational study product used in this clinical trial is a soft drink containing an arabinoxylan-oligosaccharides (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).

The objective of this study is to analyze the effect of the intake of two WBE doses on various parameters of gastrointestinal health. Additionally, safety was analyzed using treatment emergent Adverse Events (AEs) and clinical blood parameters.

Enrollment

66 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female 18-90 years of age, inclusive
Regular eating habits
Body Mass Index (BMI) between 18.5 and 30 kg/m2
Consent to take in the study product according to the study protocol
Subject is willing to maintain his or her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)
For female volunteers of childbearing potential: not planning to become pregnant during the clinical trial and willing to commit to the use of a medically approved form of contraception

Exclusion criteria

Low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial
Recent use of antibiotics
Abdominal surgery in the past
Serious illness within 3 months of start of clinical trial
Use of medication or dietary supplements known to influence GI tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti diarrhea medication and/or probiotic medication
Complete anesthetics within 1 month of the start of the clinical trial
Chronic GI conditions such as inflammatory bowel disease (IBD), inflammatory bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance
Allergy for wheat products
Celiac disease
For female volunteers: pregnant or lactating
Alcohol abuse
Smoking more than 5 cigarettes per day
Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk.