Phase
Condition
Obesity
Diabetes Prevention
Treatment
Prebiotic sachet (Prebiotic Blend), Placebo capsule
Placebo sachet, Placebo capsule
Probiotic capsule (L. reuteri PB-W1™), Prebiotic sachet (Prebiotic Blend)
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
To be considered eligible for enrolment into the study, potential Participants must:
Be able to give written informed consent.
Be between 18 and 55 years of age.
Self-identify as White.
Have a BMI of 30-40 kg/m2 and waist circumference of ≥102cm (males) or ≥88cm (females).
Have a stable body weight (≤5% change) over the past three months.
Be in general good health, as determined by interview and having systolic bloodpressure less than 160 mm Hg and diastolic blood pressure less than 100 mm Hg (defined as hypertension stage 2), taken by the investigator.
Be willing to avoid consuming dietary supplements, prebiotics, probiotics, orfibre-rich supplements within four weeks prior to the baseline visit and untilthe end of the study.
Be willing to maintain their current level of physical activity.
Be willing to consume the investigational product daily for the duration of thestudy.
Be willing to maintain their habitual diet for the duration of the study.
Exclusion
Exclusion Criteria:
Potential Participants will be excluded from the study if they meet any of the belowcriteria:
Are pregnant, lactating or post-menopausal or women who are planning to becomepregnant over the study period.
Have hypersensitivity, allergy, or intolerance to any of the components of theinvestigational products.
Have received antibiotic treatment within three months prior to baseline.
Are taking a medication that the investigator believes would interfere with theobjectives of the study, pose a safety risk, or confound the interpretation ofthe study results. Participants should have a wash-out period of two-weeks foreach of these medications except for antibiotics, which should not have beentaken in the previous three months. Participants taking proton pump inhibitorswill be allowed into the study if the dose has been stable for at least twomonths prior to baseline. Similarly, occasional use of over-the-counternon-steroidal analgesics may be acceptable (at the discretion of the ChiefInvestigator). However, participants will be required to note any medicationsconsumed via the Medical History, Medications and Supplements Log (MR2006).
Have a history or indication of drug and/or alcohol abuse at the time ofenrolment.
Have a significant active and medically diagnosed acute or chronic co-existingillness including metabolic, psychiatric, or gastrointestinal disease (such asdiarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach orduodenal ulcers, hepatitis A/B/C, HIV, cancer etc.). Participants that have asignificant family history of such diseases or any other condition whichcontraindicates, in the investigator's judgement, entry to the study will alsobe excluded.
Habitual consumption of >2 alcoholic beverages/day (>28g ethanol/day).
Are vegetarian or vegan, those with a typical fibre intake of >30g/day andthose that have used dietary supplements (prebiotics/probiotics) in the monthleading up to the study.
Have made major dietary changes within three months prior to baseline and thosewith major lifestyle changes planned during the study (e.g., diet, exercise,extensive travel etc).
Those with clinically diagnosed eating disorders.
Have active gastrointestinal disorder or previous gastrointestinal surgery.
Have a chronic medication treatment (e.g., anti-hypertensive medications) ofunstable dosage, defined as having been changed within two months prior tobaseline.
Are severely immunocompromised (HIV positive, transplant recipients, on anyanti-rejection medications, on a systemic-acting steroid for >30 days, or havehad chemotherapy or radiotherapy in the last 12 months.
Have a malignant disease or any concomitant end-stage organ disease.
Have symptomatic illness, that in the opinion of the Investigator,contraindicates entry onto the study.
Experienced alarm features such as unexplained weight loss, rectal bleeding, arecent change in bowel habits, or significant abdominal pain within threemonths prior to baseline.
Individuals who, in the opinion of the investigator, are considered to be poorattendees or unlikely for any reason to be able to comply with the trial.
Participants may not be receiving treatment involving experimental drugs.
If the Participant has been in a recent experimental trial, these must havebeen completed not less than 30 days prior to this study.
Any Participant that regularly undertakes rigorous exercise defined byInternational Physical Activity Questionnaire with a score within category 3,Health Enhancing Physical Activity (HEPA) Active.
Individuals with pacemakers or implantable cardioverter defibrillators.
Study Design
Study Description
Connect with a study center
University College Cork
Cork,
IrelandSite Not Available
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