Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spermidine, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Hyperlipidemia. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of spermidine supplementation in overweight or obese adults with hyperlipidemia.
A total of 50 eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group (spermidine capsule 10 mg/day) or the control group (placebo capsule, identical in appearance, packaging, and taste). Randomization will be performed by a third-party statistician using a computer-generated random number table with variable block sizes. Allocation concealment will be ensured through sequentially numbered, opaque, sealed envelopes. All outcome assessors, investigators, and participants will be blinded to group assignment throughout the study.
The intervention period lasts 1 month. Participants in the experimental group will take 2 capsules (10 mg total) of spermidine (extracted from North American high-selenium wheat germ, 100:1 concentration process) orally per day after breakfast. The placebo group will receive an identical regimen of microcrystalline cellulose capsules. During the trial, all participants will receive standardized dietary advice designed to avoid high-polyamine foods (e.g., natto, fermented soy products, mushroom, germ products) and maintain stable total energy intake without overeating. They will also be advised to avoid new nutritional supplements and any other weight-loss interventions. Weekly telephone follow-ups will monitor compliance and dietary/exercise logs. Compliance will be assessed by pill counts of returned capsules, with \<80% adherence defined as protocol deviation.
Assessments are scheduled at baseline (Day 0) and at study end (Month 1). Baseline evaluations include anthropometric measurements, blood biochemistry, stool sample collection, and questionnaire assessments. At Month 1, all baseline measurements will be repeated, and adverse events will be recorded and assessed for causality using the Naranjo scale. Safety monitoring includes liver and kidney function tests and documentation of gastrointestinal or other adverse reactions throughout the trial.
Primary outcome is the change in triglycerides (TG) from baseline to 1 month. Secondary outcomes include changes in LDL, total cholesterol, weight, BMI, body fat percentage, waist-to-hip ratio, fasting glucose, liver/kidney function parameters, and adverse event rates. Statistical analyses will follow the intention-to-treat principle using SAS 9.4. Primary analysis will employ two independent sample t-tests or Mann-Whitney U tests for between-group comparisons.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Triglycerides (TG) [Time frame: Baseline and 1 month post-treatment]
Secondary outcome measures (12)
- Three-Factor Eating Questionnaire - Revised 21-item(TFEQ-R21) [Time frame: Baseline and 1 month post-treatment]
- Alanine Aminotransferase [Time frame: Baseline and 1 month post-treatment]
- Fasting Blood Glucose [Time frame: Baseline and 1 month post-treatment]
- Low-Density Lipoprotein Cholesterol [Time frame: Baseline and 1 month post-treatment]
- Physical Activity Intensity [Time frame: Baseline and 1 month post-treatment]
- Total Cholesterol (TC) [Time frame: Baseline and 1 month post-treatment]
- Creatinine [Time frame: Baseline and 1 month post-treatment]
- Body Weight [Time frame: Baseline and 1 month post-treatment]
- Body Fat Percentage [Time frame: Baseline and 1 month post-treatment]
- Waist Circumference [Time frame: Baseline and 1 month post-treatment]
- Hip Circumference [Time frame: Baseline and 1 month post-treatment]
- Body Mass Index (BMI) [Time frame: Baseline and 1 month post-treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Tenth People'S Hospital — Shanghai
Identifiers
NCT: NCT07662330 · Spermidine