Spermidine supplement for lipid and weight changes in adults with obesity and high cholesterol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center, randomized, double-blind, placebo-controlled trial, 50 adults with overweight/obesity and hyperlipidemia are assigned to receive spermidine capsules or placebo for 4 weeks. Participants and study staff are unaware of group assignment, and allocation is concealed. All participants receive standardized dietary guidance to limit high-polyamine foods and maintain stable energy intake, plus weekly follow-ups. Primary outcomes focus on lipid parameters and body weight, with safety assessments including liver and kidney function and adverse events. The trial aims to determine if spermidine is a safe and effective option for managing dyslipidemia in this population.

Why it matters

Who can join: the full rules

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's running

• Shanghai Tenth People'S Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Bu Le
• Email: geyingjun@hotmail.com
• Phone: +86 17701621016

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.