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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Heart failure with preserved ejection fraction is the largest unmet need in medicine. Exercise training is a pivotal lifestyle intervention which has been shown to have beneficial effects with regards to metabolic, neurological-cognitive and cardiovascular outcomes in these patients. Yet, not every patients responds equally fast to an exercise training intervention. This trial explores whether the supplementation of spermidine can increase the response to a structured aerobic exercise training. The investigators will recruit 30 patients who will either receive a spermidine supplement or a placebo. The study participants are invited for a first follow-up visit after four weeks. The exercise intervention starts at week 5 and continues for 12 weeks. Hence, overall there are three visits (baseline, week four and week twelve).

Conditions

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Heart Failure, Diastolic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Spermidine supplementation

Study participants are provided with spermidine supplementation

Group Type EXPERIMENTAL

spermidineLife

Intervention Type DIETARY_SUPPLEMENT

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

Placebo supplementation

Study participants are provided with a placebo supplementation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

dietary supplement that is made of cellulose.

Interventions

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spermidineLife

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

dietary supplement that is made of cellulose.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No