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Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals with Hyperlipidemia

Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals with Hyperlipidemia: A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115190
Enrollment
Unknown
Registered
2025-12-23
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eligible participants had a BMI of >= 24 kg/m^2 and dyslipidemia (TG >= 1.7 mmol·L^(-1) or TC >= 5.2 mmol·L^(-1)), and were free from major chronic conditions.

Interventions

Trial group (spermidine):Spermidine capsules 10 mg/day
Control group (placebo):Placebo 10 mg/day

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 60 years; 2. No restrictions on gender; 3. Body Mass Index (BMI) >= 24 kg/m^2; 4. Documented dyslipidemia (Triglycerides >= 1.7 mmol·L^(-1) or Total Cholesterol >= 5.2 mmol·L^(-1)); 5. Provides signed and dated informed consent;

Exclusion criteria

Exclusion criteria: 1.Diagnosis of acute or severe gastrointestinal disease; 2.Concurrent participation in any other weight-loss therapy; 3.Current use of hypoglycemic or lipid-lowering medications; 4.Participation in any other clinical trial within one month prior to signing the informed consent form; 5.Pregnancy, lactation, or planning a pregnancy during the trial period; 6.Known allergy to cellulose or wheat; 7.History of cancer; 8.Renal insufficiency, indicated by abnormal serum creatinine levels; 9.Hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN), or total bilirubin (TBIL) >3 × ULN; 10.Any other condition deemed by the investigator as inappropriate for trial participation;

Design outcomes

Primary

MeasureTime frame
Triglycerides (TG);

Secondary

MeasureTime frame
Appetite Score;Quality of Life;Alanine Aminotransferase;Fasting Blood Glucose;Physical Activity Intensity;Low-Density Lipoprotein Cholesterol;Total Cholesterol (TC);Creatinine;Anthropometric Measurements;

Countries

China

Contacts

Public ContactBu Le

Shanghai Tenth People's Hospital

geyingjun@hotmail.com+86 21 66303542

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026