Randomized, Double-Blind Study of Spermidine Supplementation Effects on Blood Lipids and Weight in Overweight or Obese Adults with Hyperlipidemia

What this Trial Is About

Researchers are evaluating the effects of spermidine supplementation on blood lipid levels and body weight in adults who are overweight or obese with hyperlipidemia. This randomized, double-blind, placebo-controlled trial aims to assess changes in lipid profiles, metabolic parameters, and the safety of spermidine, including impacts on liver and kidney function and potential adverse effects. Participants will be randomly assigned to receive either spermidine capsules totaling 10 mg per day or matching placebo capsules daily for one month. Both groups will follow standardized dietary guidance to avoid high-polyamine foods and maintain stable energy intake, with weekly phone follow-ups to monitor adherence and lifestyle. The trial includes baseline and one-month assessments. During the study, participants undergo measurements such as blood tests for lipids and glucose, body weight and composition evaluations, stool sample collection, and questionnaires at both the start and end of the one-month period. Safety monitoring involves tracking liver and kidney function and any gastrointestinal or other adverse reactions. The main outcome measured is the change in triglycerides from baseline to one month, with several secondary outcomes also evaluated.

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