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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: A Randomized, Double-Blind, Placebo-Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Shanghai Tenth People'S Hospital
RECRUITING
Shanghai
Contact Information
Primary
Bu Le
geyingjun@hotmail.com
+86 17701621016
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 50
Treatments
Experimental: Trial group (spermidine)
Spermidine capsules 10 mg/day
Placebo_comparator: Control group (placebo)
Placebo 10 mg/day
Related Therapeutic Areas
Sponsors
Leads: Shanghai 10th People's Hospital

This content was sourced from clinicaltrials.gov

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