Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia
Spermidine: Spermidine (10 mg/day) administered as two oral capsules taken after breakfast. The spermidine is extracted from North American high-selenium wheat germ using a 100:1 concentration process. Each capsule contains 5 mg of spermidine, with a total daily dose of 10 mg. The intervention duration is 1 month.
Placebo: Placebo capsules are identical in appearance, color, size, packaging, and taste to the spermidine capsules. Each capsule is filled with microcrystalline cellulose and contains no active ingredients. Participants will take two placebo capsules orally after breakfast daily for a duration of 1 month. The placebo is packaged and blinded by an independent pharmacy according to a randomization code to ensure double-blind implementation.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Triglycerides (TG) — Baseline and 1 month post-treatment Change in fasting serum triglycerides (TG) from baseline (Day 0) to the end of the 1-month intervention period. Blood samples are collected after an overnight fast and analyzed using standard enzymatic methods. TG level is measured in mmol/L. This is the primary efficacy outcome of the study.
Trial sites (1)
Facility
City
Region
Status
Shanghai Tenth People'S Hospital
Shanghai
Shanghai Municipality
Recruiting
More Shanghai 10th People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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