Trial Outcomes & Findings for Impact of Nutritional Supplementation on Aerobic Performance and Fatigue (NCT NCT02134756)

Results Overview

Ratings of perceived exertion (RPE) as measured on a self-report scale. The scale is a single-item measure ranging from 0 (no exertion) to 10 (max exertion).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

28 days

Results posted on

2020-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	NutraStem Active 2 capsules per day for 28 days	Placebo 2 capsules per day for 28 days
Overall Study STARTED	15	15
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Nutritional Supplementation on Aerobic Performance and Fatigue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NutraStem Active n=15 Participants Daily supplementation with NutraStem Active; 2 capsules per day for 28 days NutraStem Active	Placebo n=15 Participants Daily supplementation with placebo; 2 capsules per day for 28 days NutraStem Active	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	23 Perceived Exertion STANDARD_DEVIATION 6 • n=5 Participants	26 Perceived Exertion STANDARD_DEVIATION 7 • n=7 Participants	25 Perceived Exertion STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Perceived Exertion	7.5 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	7.5 units on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	7.5 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Ratings of perceived exertion (RPE) as measured on a self-report scale. The scale is a single-item measure ranging from 0 (no exertion) to 10 (max exertion).

Outcome measures

Outcome measures
Measure	NutraStem Active n=14 Participants Daily supplementation with NutraStem Active; 2 capsules per day for 28 days NutraStem Active	Placebo n=13 Participants Daily supplementation with placebo; 2 capsules per day for 28 days NutraStem Active
Perceived Exertion	6.7 units on a scale Standard Deviation 2.0	7.4 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 28 days

Ratings of perceived fatigue as measured on a self-report scale. The scale is a single-item measure ranging from 1 (not at all) to 5 (extremely).

Outcome measures

Outcome measures
Measure	NutraStem Active n=14 Participants Daily supplementation with NutraStem Active; 2 capsules per day for 28 days NutraStem Active	Placebo n=13 Participants Daily supplementation with placebo; 2 capsules per day for 28 days NutraStem Active
Perceived Fatigue	5.8 units on a scale Standard Deviation 1.9	5.5 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 28 days

Ratings of perceived energy as measured on a self-report scale. The scale is a single-item measure ranging from 1 (not at all) to 5 (extremely).

Outcome measures

Outcome measures
Measure	NutraStem Active n=14 Participants Daily supplementation with NutraStem Active; 2 capsules per day for 28 days NutraStem Active	Placebo n=13 Participants Daily supplementation with placebo; 2 capsules per day for 28 days NutraStem Active
Perceived Energy	4.1 units on a scale Standard Deviation 1.7	4.6 units on a scale Standard Deviation 1.6

Adverse Events

NutraStem Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcus Kilpatrick

University of South Florida

Phone: (813) 362-6696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place