Nutritional Therapy for Autonomic Dysfunction in Elderly Heart Failure Patients

What Was Tested

This registered not phased trial tested L-Carnitine.

It had two arms (groups): Whey protein powder and L-carnitine capsules (experimental) and Maltodextrin placebo powder and Psyllium Husk capsules (placebo comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

It is a major cause of morbidity and mortality and is the leading cause of hospitalization among older individuals in the United States (1-15), particularly among those aged ≥65 years (16, 18).

The endothelium helps in regulating the vascular tone by balancing the production of vasodilators and vasoconstrictors in response to various stimuli (36) and its dysfunction would also impair baroreceptor function which in turn would affect cardiac autonomic activity and blood flow.

Who Took Part

21 actual participants took part.

It was open to women only aged from 60 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Mild to moderate heart failure (NYHA I, II, or III symptomology) as confirmed by study physician.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: moderately-severe dementia (moca score); active inflammatory bowel disease; active cancer or chemotherapy in the past year.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-07-26 with completion listed for 2018-01-11.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Cardiovascular assessment of blood pressure (time frame: Change from baseline to 16 weeks). Cardiovascular assessment (time frame: Change from baseline to 16 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.