Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia
Recruiting · NCT07662330 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai 10th People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSpermidine
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Males or females aged 18 to 65 years.
- BMI ≥ 24 kg/m², without severe chronic diseases.
- Not currently using glucose-lowering or lipid-lowering medications.
- Dyslipidemia defined as triglycerides ≥ 1.7 mmol/L or total cholesterol ≥ 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 × upper limit of normal (ULN), or total bilirubin (TBIL) \>3 × ULN
- Any other condition deemed by the investigator as inappropriate for trial participation
Where it is running
1 location listed.
- Shanghai Tenth People'S Hospital - Shanghai, Shanghai Municipality, China