sPERMIdine supplemenTation on Metabolic, Neuronal and Cardiovascular Response to Exercise TRAINING

NCT05128331 | Unknown

• 1 other identifier: PERMIT-HGW-DZHK40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores whether spermidine supplementation improves the metabolic, neurological-cognitive and cardiovascular response to structured exercise training in patients with heart failure with preserved ejection fraction. The investigators aim to show that a faster adaptation to exercise may improve long term adherence to a more active lifestyle.

Conditions

Heart Failure, Diastolic

Keywords

Exercise; Spermidine

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory exercise capacity

  Change in cardiorespiratory exercise capacity (VO2peak) in ml/min/kg before and after of exercise training

  16 weeks

Secondary Outcomes (2)

• Diastolic function

  16 weeks

• Microvascular function

  16 weeks

Other Outcomes (8)

• Multiple-Choice Vocabulary Intelligence Test (MWT-B)

  16 weeks

• Mnemonic Similarity Task (MST)

  16 weeks

• Verbal Learning and Memory Test (VLMT)

  16 weeks

Study Arms (2)

Spermidine supplementation

EXPERIMENTAL

Study participants are provided with spermidine supplementation

Dietary Supplement: spermidineLife

Placebo supplementation

PLACEBO COMPARATOR

Study participants are provided with a placebo supplementation

Dietary Supplement: Placebo

Interventions

spermidineLife DIETARY_SUPPLEMENT

dietary supplement that is made of natural wheat germ extract with high spermidine content

Spermidine supplementation

Placebo DIETARY_SUPPLEMENT

dietary supplement that is made of cellulose.

Placebo supplementation

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diastolic heart failure (E/e' \> 8, left ventricular ejection fraction (LVEF) =\> 50 %, dyspnea)

You may not qualify if:

• nutritional supplements with polyamines
• acute myo-, endo- or pericarditis
• aortic valve stenosis (2nd degree)
• cardiomyopathy or severe left ventricular hypertrophy (Interventricular septal end diastolic thickness or posterior wall thickness \> 17 mm)
• AV block (second degree)
• pulmonary hypertension
• thromboembolic event in the last six months
• anemia
• infection (with fever) within the last four weeks
• cancer

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Cardiovascular examination center of the University Medicine Greifswald

Greifswald, 17489, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure, Diastolic; Motor Activity

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Marcus Dörr, MD

CONTACT

+4938348680500; marcus.doerr@med.uni-greifswald.de

Martin Bahls, PhD

CONTACT

+4938348680500; martin.bahls@med.uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: November 22, 2021
• Study Start: August 11, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 25, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)