๐ฌIn plain words
What the trial is, and whether it could suit you
Evaluate the effect of spermidine supplementation on lipid profile changes in individuals with overweight or obesity accompanied by hyperlipidemia. Analyze the impact of spermidine on metabolic parameters and assess the safety of spermidine supplementation, including liver and kidney function, gastrointestinal reactions, and other adverse effects.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Males or females aged 18 to 65 years.
* BMI โฅ 24 kg/mยฒ, without severe chronic diseases.
* Not currently using glucose-lowering or lipid-lowering medications.
* Dyslipidemia defined as triglycerides โฅ 1.7 mmol/L or total cholesterol โฅ 5.2 mmol/L.
* No active weight loss or weight gain diet within the past 1 month.
* No special dietary pattern changes (e.g., ketogenic, vegan, high-protein, meal replacement, intermittent fasting) within the past 1 month.
* No use of supplements that may affect polyamine intake (e.g., germ, yeast, fermented extracts, nutritional powders) within the past 2-4 weeks.
* Willing and able to provide signed informed consent.
Exclusion Criteria:
* Diagnosis of acute or severe gastrointestinal disease
* Concurrent participation in any other weight-loss therapy
* Current use of hypoglycemic or lipid-lowering medications
* Participation in any other clinical trial within one month prior to signing the informed consent form
* Pregnancy, lactation, or planning a pregnancy during the trial period
* Known allergy to cellulose or wheat
* History of cancer
* Renal insufficiency, indicated by abnormal serum creatinine levels
* Hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ร upper limit of normal (ULN), or total bilirubin (TBIL) \>3 ร ULN
* Any other condition deemed by the investigator as inappropriate for trial participation