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

NCT07662330 | Recruiting

• 1 other identifier: Spermidine
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Triglycerides (TG)

  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.

  Baseline and 1 month post-treatment

Secondary Outcomes (12)

• Three-Factor Eating Questionnaire - Revised 21-item(TFEQ-R21)

  Baseline and 1 month post-treatment

• Alanine Aminotransferase

  Baseline and 1 month post-treatment

• Fasting Blood Glucose

  Baseline and 1 month post-treatment

• Low-Density Lipoprotein Cholesterol

  Baseline and 1 month post-treatment

• Physical Activity Intensity

  Baseline and 1 month post-treatment

Study Arms (2)

Trial group (spermidine)

EXPERIMENTAL

Spermidine capsules 10 mg/day

Drug: Spermidine

Control group (placebo)

PLACEBO COMPARATOR

Placebo 10 mg/day

Drug: Placebo

Interventions

Spermidine DRUG

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.

Trial group (spermidine)

Placebo DRUG

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.

Control group (placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People'S Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Hyperlipidemias

Interventions

Spermidine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Putrescine; Biogenic Polyamines; Biogenic Amines; Amines; Organic Chemicals; Polyamines

Central Study Contacts

Bu Le

CONTACT

+86 17701621016; geyingjun@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, principal investigator, clinical professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: June 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)