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NCT07662330Recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
7 Apr 2026
Start date
1 Jan 2026
Primary completion date
31 Dec 2026
Lead sponsor
Shanghai 10th People's Hospital
Diseases
Obesity
NCT number
NCT07662330

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Jan 2026 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Diagnosis of acute or severe gastrointestinal disease
  • Known allergy to cellulose or wheat
  • History of cancer
  • Any other condition deemed by the investigator as inappropriate for trial participation

Lab values

  • 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

Other

  • Pregnancy, lactation, or planning a pregnancy during the trial period

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Tenth People's Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.