Trial Outcomes & Findings for Oxidative Stress Links Aging, Activity, and Mobility Limitation (NCT NCT01177189)

NCT ID: NCT01177189

Last Updated: 2019-02-21

Results Overview

The effect on flow mediated vasodilation is measured using Doppler ultrasound.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 87 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2019-02-21

Participant Flow

Participant milestones

Measure	Arm 1 Young healthy men and women aged 18-30 Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily	Arm 2 Older healthy men and women aged \>70. Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily
Overall Study STARTED	42	45
Overall Study COMPLETED	42	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Arm 1 n=42 Participants Young healthy men and women aged 18-30 Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily	Arm 2 n=45 Participants Older healthy men and women aged \>70. Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=42 Participants	0 Participants n=45 Participants	0 Participants n=87 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=42 Participants	0 Participants n=45 Participants	42 Participants n=87 Participants
Age, Categorical >=65 years	0 Participants n=42 Participants	45 Participants n=45 Participants	45 Participants n=87 Participants
Sex: Female, Male Female	21 Participants n=42 Participants	17 Participants n=45 Participants	38 Participants n=87 Participants
Sex: Female, Male Male	21 Participants n=42 Participants	28 Participants n=45 Participants	49 Participants n=87 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	42 Participants n=42 Participants	45 Participants n=45 Participants	87 Participants n=87 Participants

PRIMARY outcome

Timeframe: 8 weeks

The effect on flow mediated vasodilation is measured using Doppler ultrasound.

Outcome measures

Measure	Arm 1 n=42 Participants Young healthy men and women aged 18-30 Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily	Arm 2 n=45 Participants Older healthy men and women aged \>70. Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily
Vascular Function (i.e. % Flow Mediated Vasodilation)	7.4 percentage of vasodilation Standard Error 0.6	5.2 percentage of vasodilation Standard Error 0.4

SECONDARY outcome

Timeframe: 8 weeks

Free radicals and levels of lipid peroxidation were measured using electron paramagnetic spectroscopy and ELISA assays.

A minimum value is 0 and a maximum value is 10. A higher value is a worse outcome.

Outcome measures

Measure	Arm 1 n=42 Participants Young healthy men and women aged 18-30 Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily	Arm 2 n=45 Participants Older healthy men and women aged \>70. Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily
Exercise-induced Oxidative Stress (i.e. Free Radical Concentrations and Levels of Lipid Peroxidation)	1.51 units on a scale Standard Error 0.19	2.7 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: 8 weeks

The degree of vasodilation following the antioxidant intervention measured by Doppler ultrasound.

Outcome measures

Measure	Arm 1 n=42 Participants Young healthy men and women aged 18-30 Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily	Arm 2 n=45 Participants Older healthy men and women aged \>70. Vitamins C, E, and alpha lipoic acid: Oral antioxidant cocktail or placebo to be consumed daily
Vascular Function Following the Antioxidant Intervention	5.8 percentage of vasodilation Standard Error 0.6	8.2 percentage of vasodilation Standard Error 0.6

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

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

Van Reese

Salt Lake City VAMC

Phone: 801 582 1565

Email: van.reese@hsc.utah.edu

Results disclosure agreements

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