Phase
Condition
Hypertriglyceridemia
Obesity
Treatment
Fibre-enriched diet
Control diet
Clinical Study ID
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be willing and able to give written informed consent.
Be between 18 and 45 years of age
Have a Body Mass Index (BMI) of 25-34.9kg/m2 (Overweight or Obese Class I)
Have had a stable body weight (≤5% change over the past three months)
Be in general good health as determined by the investigator through interview andvital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertensionstage 2).
Be willing to avoid consuming dietary supplements, prebiotics, probiotics, orfibre-rich supplements within four weeks prior to the baseline visit, and until theend of the study.
Be willing to avoid physical exercise for the duration of the study (physicalexercise defined as any physical activity that is planned to achieve a fitness goal)
Be willing to consume the investigational products daily for the duration of thestudy.
Exclusion
Exclusion Criteria:
Pregnant, lactating, menopausal or post-menopausal women, or women who are planningto become pregnant over the study period.
Have had 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 of studyresults; to include: anti-inflammatory drugs, H2 blockers, antacid, proton pumpinhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas,antibiotics, anti-coagulants, immunosuppressant medication. Participants should havea wash-out period of at least two-weeks for each of these medications except forantibiotics, which should not have been taken in the previous three months.Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed onto the study if the dose hasbeen stable for at least two months prior to the study baseline visit.
Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
Have a habitual alcohol consumption of >2 alcoholic beverages/day (>28g ethanoldaily).
Follow a vegetarian or vegan diet
Have a typical fibre intake of >30g per day
Have experienced major dietary changes within three months prior to the studybaseline.
Plan major lifestyle changes (diet, physical activity, or travel) during the studyperiod.
Have a clinically diagnosed eating disorder.
Have a food allergy or intolerance that would preclude study product intake (forexample eggs, gluten, nuts, milk or any other food allergy or intolerance)
Have an active gastrointestinal disorder or previous gastrointestinal surgery
Have a significant active and medically-diagnosed acute or chronic co-existingillness including: metabolic, psychiatric, cardiovascular, endocrinological,immunological condition, gastrointestinal disease or any other condition whichcontraindicates, in the investigator's judgement, entry to the study (such as,diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome,diverticulosis, stomach or duodenal ulcers, hepatitis A/B/C, HIV, cancer, diabetesetc) or a significant history of such diseases.
Are severely immunocompromised (e.g., HIV positive, transplant patient, onanti-rejection medications, on a steroid for >30 days, or chemotherapy orradiotherapy within the last 12 months).
Have a malignant disease or concomitant end-stage organ disease.
Have symptomatic respiratory or cardiac illness.
Experience alarm features such as sudden weight loss, rectal bleeding, a recentchange in bowel habits, or significant abdominal pain within three months prior tobaseline.
Individuals who, in the opinion of the investigator are poor attendees or unlikelyfor any reason to be able to comply with the study protocol.
Participants may not be receiving treatment involving experimental drugs.
If the participant has been in a recent experimental trial, these must have beencompleted not less than 30 days prior to this study.
Individuals with pacemakers or implantable cardioverter defibrillators.
Individuals that regularly undertake rigorous exercise, defined by InternationalPhysical Activity Questionnaire with a score within category 3, Health EnhancingPhysical Activity (HEPA) Active.
Individuals who smoke or vape regularly (i.e., daily or habitual use).
Study Design
Study Description
Connect with a study center
University College Cork
Cork,
IrelandActive - Recruiting

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