Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT03581812
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Aged between 18-45 years
* Body mass index (BMI) of 18.5 - 29.9 kg/m2
* Regular consumption of snacks (≥2 per day, excluding fruit and nut snacks)
* Low fibre intake (\<22 g/d)
* Willing to follow the protocol and provide consent
Exclusion Criteria:
* Allergy or intolerance to snack ingredients (assessed at screening)
* Dislike of study snacks
* Regular consumption of intervention foods as snacks (twice a day in last month)
* Diabetes
* Major active psychiatric conditions (e.g. schizophrenia) or current eating disorder
* Active treatment for cancer in the last year
* Severe renal, cardiac or pulmonary disease or any other chronic medical condition
* Severe oesophagitis, gastritis or duodenitis
* Active diverticulitis or intestinal/colonic strictures
* Crohns disease or Ulcerative colitis
* Abdominal surgery (except appendicectomy or cholecystectomy)
* Irritable bowel syndrome
* Functional constipation
* Functional diarrhoea
* Antibiotics (past 4 weeks)
* Ongoing therapy with drugs affecting gastrointestinal motility
* Use of medical devices (Pacemakers, infusion pumps, insulin pumps)
* Women who are pregnant/lactating/planning pregnancy
* Recent/ongoing consumption of probiotics/prebiotics (past 4 weeks)
* Ongoing abuse of alcohol/drugs/other medication
* Very high physical activity levels
* Unexplained/unintentional weight loss in the past 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03581812
Study Brief:
Protocol Section:
NCT03581812