DRKS00040859RecruitingNot Applicable
Safety and Pharmacokinetics of Spermidine Supplementation in Adults with BMI = 27 kg/m²: An Ascending Dose Study - SPADE
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 45 Years to 64 Years (—)
- Sex
- All
Inclusion Criteria
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Female (post-menopausal ) or male.
- •Aged 45-65 years (both inclusive) at the time of signing informed consent.
- •Body Mass Index (BMI) = 27kg/m² at screening.
- •To be in a generally healthy state with stable excess body weight/obesity based on the medical history, physical examination, and screening results (vital signs, electrocardiogram, and clinical laboratory tests), as judged by the investigator.
Exclusion Criteria
- •Known hypersensitivity, intolerance, or allergy to wheat sprouts, gluten, or to spermidine.
- •Participation in any other interventional clinical trial within 30 days (or 5 half-lives of the investigational product, whichever is greater) prior to screening.
- •Unwillingness or inability to consume the investigational food supplement or standardised study meals (polyamine-freecontrolled) provided during trial visits.
- •Special diets (i.e., extreme diets, defined as
- •Extreme restriction of individual nutrients (i.e., diets that are heavily reduced in carbohydrates, fat or protein, such as "low carb" (less than 100g carbohydrates/day or less than 30% of total calories from carbohydrates));
- •Ketogenic diets, or “elimination diets” (i.e., omission of specific foods in order to observe health effects);
- •Mono diets (i.e., diets consisting of only a few or one food (e.g. potato diet));
- •Diets with unusual meal frequencies or times (e.g., intermittent fasting or diets with atypical eating times (‘timerestricted eating’ (TRE), i.e., intentionally restricting one’s eating window to <8 h per day on =5 days per week))
- •Adherence to a vegan diet
- •Presence of any clinically significant gastrointestinal disorder potentially affecting absorption of drugs or nutrients, including but not limited to chronic inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), irritable bowel syndrome, celiac disease, or prior bariatric surgery, as judged by the investigator.
- •Current use of spermidine-containing supplements, use within 4 weeks prior to screening, or habitual adherence to a high-spermidine diet, as judged by the investigator.
- •Active smoking status, defined as current use of any tobacco product, or former smoking with cessation less than 3 years prior to screening.
- •Habitual alcohol consumption exceeding 15 standard drinks per week (1 standard drink = 330 mL beer / 125 mL wine / 40 mL spirits), or a positive alcohol breath test at screening.
- •History of illicit drug abuse or a positive urine drug screen at screening. Note: A positive opiate result attributable to recent poppy seed consumption may be retested at the investigator's discretion.
- •History of any clinically significant condition, including but not limited to:
- •Active or prior malignancy (see EC 18 for detailed oncology criteria)
- •Diabetes mellitus (Type 1 or Type 2)
- •Clinically significant cardiovascular disease, including uncontrolled hypertension (see EC 22 for blood pressure thresholds), unstable angina, or decompensated heart failure
- •Significant hepatic impairment (see EC 19 for laboratory thresholds)
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 80 mL/min/1.73 m2 (CKD-EPI 2021 equation)
- •Clinically significant ECG abnormalities, as judged by the investigator
- •Any other condition which, in the opinion of the investigator, would compromise participant safety or data integrity
- •History of any vaccination within 30 days prior to screening or planned during the study period.
- •Use of antibiotics within 4 weeks prior to screening and planned during the trial duration.
- •Use of dual hormone agonists, GLP-1 receptor agonists, or other pharmacological weight-loss therapies within 3 months prior to screening, or planned use during the study period, as judged by the investigator.
- •Current or planned pregnancy or breastfeeding during the trial period. Females of childbearing potential must have a negative pregnancy test at screening.
Investigators
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