Trial Outcomes & Findings for Nutritional Therapy Interventions in Heart Failure (NCT NCT03424265)

NCT ID: NCT03424265

Last Updated: 2021-07-12

Results Overview

Measuring 6 minutes walking before and after the intervention. \*\*\*The results below are the actual increases of walking distance (mean and SD) changes from baseline to end of 12-week intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: Change from baseline to 12 weeks
• Results posted on: 2021-07-12

Participant Flow

Participant milestones

Measure	9g of EAA Mixture Supplement Twice a day for 12 consecutive weeks. EAA mixture: Dietary supplement intervention for 12-weeks	9g of Placebo (Whey Protein) Twice a day for 12 consecutive weeks. Placebo (whey protein): Dietary supplement intervention for 12-weeks
Overall Study STARTED	29	34
Overall Study COMPLETED	28	32
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	9g of EAA Mixture Supplement Twice a day for 12 consecutive weeks. EAA mixture: Dietary supplement intervention for 12-weeks	9g of Placebo (Whey Protein) Twice a day for 12 consecutive weeks. Placebo (whey protein): Dietary supplement intervention for 12-weeks
Overall Study screening failure	1	0
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Nutritional Therapy Interventions in Heart Failure

Baseline characteristics by cohort

Measure	9g of EAA Mixture Supplement n=29 Participants Twice a day for 12 consecutive weeks. EAA mixture: Dietary supplement intervention for 12-weeks	9g of Placebo (Whey Protein) n=34 Participants Twice a day for 12 consecutive weeks. Placebo (whey protein): Dietary supplement intervention for 12-weeks	Total n=63 Participants Total of all reporting groups
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized African-American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Customized Age >=60 years.	29 Participants n=5 Participants	34 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Measuring 6 minutes walking before and after the intervention. ***The results below are the actual increases of walking distance (mean and SD) changes from baseline to end of 12-week intervention.

Outcome measures

Measure	9g of EAA Mixture Supplement n=28 Participants Twice a day for 12 consecutive weeks. EAA mixture: Dietary supplement intervention for 12-weeks	9g of Placebo (Whey Protein) n=32 Participants Twice a day for 12 consecutive weeks. Placebo (whey protein): Dietary supplement intervention for 12-weeks
Functional Test	115.91 feet Standard Deviation 94.727	57.25 feet Standard Deviation 150.527

Adverse Events

9g of EAA Mixture Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

9g of Placebo (Whey Protein)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	9g of EAA Mixture Supplement n=29 participants at risk Twice a day for 12 consecutive weeks. EAA mixture: Dietary supplement intervention for 12-weeks	9g of Placebo (Whey Protein) n=34 participants at risk Twice a day for 12 consecutive weeks. Placebo (whey protein): Dietary supplement intervention for 12-weeks
Reproductive system and breast disorders Prostate pain during urination	0.00% 0/29 • Subjects were followed for adverse events for the duration of their participation (approx. 4 months).	2.9% 1/34 • Number of events 1 • Subjects were followed for adverse events for the duration of their participation (approx. 4 months).
Respiratory, thoracic and mediastinal disorders Respiratory issue	0.00% 0/29 • Subjects were followed for adverse events for the duration of their participation (approx. 4 months).	2.9% 1/34 • Number of events 1 • Subjects were followed for adverse events for the duration of their participation (approx. 4 months).
Vascular disorders hypertension	0.00% 0/29 • Subjects were followed for adverse events for the duration of their participation (approx. 4 months).	2.9% 1/34 • Number of events 1 • Subjects were followed for adverse events for the duration of their participation (approx. 4 months).

Additional Information

Scott Schutzler, R.N.

University of Arkansas for Medical Sciences

Phone: 501-526-5734

Email: seschutzler@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place