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:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT05722158
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers to avoid any possible hormonal interference.
* Between 25-45 years old (both included).
* Body weight is 70 kg (60-80 kg (both included), the range depends on the body mass index (BMI). BMI in normal (healthy weight and overweight) range: 18.5 to 29.9 kg/m2. (Reference: WHO and CDC).
* Co-operative and available during the study period.
* Subjects with capacity to understand the purpose and protocol of the study and sign the Informed Consent.
Exclusion Criteria:
* \- Diagnosis of allergies to gelatin, red meat (Alpha Gal Syndrome) or fish.
* Diagnosis of diseases about collagen metabolism such as Goodpasture syndrome, scleroderma, periarteritis nodosa or polyarteritis, dermatomyositis, and disseminated lupus erythematosus.
* Diagnosis of following chronic Gastro-Intestinal Tract diseases blocking transfer of polypeptides from GIS to the blood such as: Peptic Ulcer, Duodenal Ulcer, Chronic Atrophic Gastritis, Helicobacter Pylori, Chronic Peptic Disorders, Chronic Acid Reflux = GER and GERD, Celiac Disease, Crohn's Disease, Irritable Bowel Syndrome, Lactose Intolerance, Diverticulitis, Diverticulosis.
* Diagnosis of any diseases such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease.
* Consume more than the recommended alcohol guidelines i.e. \>21 alcohol units/week for males and \>14 units/week for females (europa.eu).
* Current smoking habit or history of smoking within the past 1 year.
* History of depression, schizophrenia, alcoholism, drug addiction, or mental illness.
* Current or previous intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
* History of asthma or autoimmune disease Use of oral hormone therapies ie. cortisone or steroids in the 6 months prior to initiation of the study.
* Abnormal liver function or abnormal renal function.
* Blood pressure \>140/90 mmHg or hypertension with intake of a diuretic.
* No participation to another clinical trial in the last 6 months.
* No blood donation within a month.
* Problems with overall findings in blood-test results as determined by a specialist.
* Any condition judged by the investigator to be unsuitable for participation in the study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
45 Years
Study:
NCT05722158
Study Brief:
Protocol Section:
NCT05722158