Polyamine Treatment in Elderly Patients With Coronary Artery Disease — PolyCAD  

Obesity Clinical Trial

Official title: Polyamine Treatment in Elderly Patients With Coronary Artery Disease - a Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

The present study is testing spermidine treatment in elderly patients with coronary artery disease. The study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.

Clinical Trial Description

Life expectancy has increased tremendously over the past century and as populations age, chronic diseases such as cardiovascular disease and diabetes have become more prevalent. Healthy aging is therefore of paramount importance to further promote longevity and quality of life.

In humans, a high concentration of whole-blood spermidine is associated with longevity, and individuals with a high dietary spermidine intake have improved cardiovascular health and less obesity. Spermidine is essentially a polyamine found in all plant-derived foods, particularly in whole grains, soybeans, nuts, and fruit. Its favorable effects may act via several mechanisms. In an experimental model of hypertensive heart disease, spermidine reduced cardiac hypertrophy and improved diastolic and mitochondrial function. Spermidine also induces cytoprotective autophagy in skeletal muscle and alters body fat accumulation by metabolically modulating glucose and lipid metabolism.

The clinical data on spermidine dietary supplementation are scarce. In elderly subjects with cognitive problems, spermidine supplement was well tolerated and had potential blood-pressure-lowering effects. The reported beneficial effects of spermidine raise the question whether elderly patients with cardiovascular disease can benefit from a dietary supplement of this polyamine.

The central hypothesis of the current proposal is that a twelve-month spermidine treatment regimen in elderly patients with cardiovascular disease will yield positive effects on heart and skeletal muscle function, whole body composition and inflammation. The secondary hypotheses are that spermidine reduces blood pressure and has a beneficial impact on cognitive function, daily activity level, quality of life, biomarker risk profile, skeletal muscle cellular metabolism and lastly but not least gut microbiota.

The study design is a randomized, double-blind, placebo-controlled trial to investigate the effects of a 24 mg daily oral spermidine dietary supplement vs. matching placebo in elderly patients with cardiovascular disease. A total of 200 patients will be included and randomized 1:1 to either spermidine 24 mg x 1 daily or matching placebo for one year.

At baseline and after one year of intervention the patients will undergo study procedures. Changes from baseline to follow-up will be compared between the active and placebo treated patient groups. ;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognition Disorder
• Cognition Disorders
• Cognitive Impairment
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diastolic Dysfunction
• Dietary Habits
• Heart Diseases
• Hypertension
• Hypertensive Heart Disease
• Inflammation
• Ischemic Heart Disease
• Metabolic Syndrome
• Myocardial Infarction
• Myocardial Ischemia
• Obesity
• Quality of Life

• NCT number: NCT06186102
• Study type: Interventional
• Source: University of Aarhus
• Contact: Christian V Thorup, MD
• Phone: 0045 51509421
• Email: christian.thorup@clin.au.dk
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Completion date: January 2027