Trial Outcomes & Findings for Impact of Smoking Cessation and γ-Tocopherol to Restore Vascular Endothelial Function (NCT NCT01314443)

Results Overview

Flow-mediated dilation (FMD) of the brachial artery is measured to assess vascular endothelial function. FMD is obtained by monitoring change in vessel diameter before and after brachial artery occlusion with a blood pressure cuff. The unit of FMD is % and is calculated using the following equation: FMD = \[(peak dilation at post occlusion - vessel diameter at preocclusion)/vessel diameter at preocclusion\]\*100.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

67 participants

Primary outcome timeframe

Day 0 and 7 of intervention

Results posted on

2015-01-21

Participant Flow

Recruitment took place in and around the community surrounding the University of Connecticut. Recruitment occurred from 2010-2011.

Health status of participants was determined from a comprehensive metabolic panel as well as circulating lipid levels. Individuals having serum chemistries outside of acceptable limits were not enrolled.

Participant milestones

Participant milestones
Measure	Dietary Supplement + Smoking Cessation Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids	Placebo + Smoking Cessation Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids	Dietary Supplement + Nicotine Replacement Therapy Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy	Placebo + Nicotine Replacement Therapy Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
Overall Study STARTED	18	19	15	15
Overall Study COMPLETED	14	16	13	13
Overall Study NOT COMPLETED	4	3	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dietary Supplement + Smoking Cessation Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids	Placebo + Smoking Cessation Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids	Dietary Supplement + Nicotine Replacement Therapy Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy	Placebo + Nicotine Replacement Therapy Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
Overall Study Withdrawal by Subject	2	1	1	1
Overall Study Protocol Violation	2	2	1	1

Baseline Characteristics

Impact of Smoking Cessation and γ-Tocopherol to Restore Vascular Endothelial Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supplement + Smoking Cessation n=14 Participants Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids	Placebo + Smoking Cessation n=16 Participants Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids	Supplement + Nicotine Replacement Therapy n=13 Participants Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of NRT	Placebo + Nicotine Replacement Therapy n=13 Participants Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of NRT	Total n=56 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	56 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	22 years STANDARD_DEVIATION 4 • n=5 Participants	22 years STANDARD_DEVIATION 4 • n=7 Participants	26 years STANDARD_DEVIATION 8 • n=5 Participants	25 years STANDARD_DEVIATION 8 • n=4 Participants	24 years STANDARD_DEVIATION 6 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	37 Participants n=21 Participants
Region of Enrollment United States	14 participants n=5 Participants	16 participants n=7 Participants	13 participants n=5 Participants	13 participants n=4 Participants	56 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 0 and 7 of intervention

Population: Analysis was performed on all participants completing the 7 d intervention

Flow-mediated dilation (FMD) of the brachial artery is measured to assess vascular endothelial function. FMD is obtained by monitoring change in vessel diameter before and after brachial artery occlusion with a blood pressure cuff. The unit of FMD is % and is calculated using the following equation: FMD = \[(peak dilation at post occlusion - vessel diameter at preocclusion)/vessel diameter at preocclusion\]\*100.

Outcome measures

Outcome measures
Measure	Dietary Supplement + Smoking Cessation n=14 Participants Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids	Placebo + Smoking Cessation n=16 Participants Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids	Dietary Supplement + Nicotine Replacement Therapy n=13 Participants Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy	Placebo + Nicotine Replacement Therapy n=13 Participants Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
Absolute Change in Brachial Artery Flow-mediated Dilation at Day 7 From Day 0	4.08 % of preocclusion diameter Standard Error 0.61	2.77 % of preocclusion diameter Standard Error 0.35	2.97 % of preocclusion diameter Standard Error 0.51	2.66 % of preocclusion diameter Standard Error 0.44

SECONDARY outcome

Timeframe: Day 0 and 7 of intervention

Plasma measurements of gamma-tocopherol was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation.

Outcome measures

Outcome measures
Measure	Dietary Supplement + Smoking Cessation n=14 Participants Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids	Placebo + Smoking Cessation n=16 Participants Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids	Dietary Supplement + Nicotine Replacement Therapy n=13 Participants Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy	Placebo + Nicotine Replacement Therapy n=13 Participants Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
Absolute Change From Baseline in Plasma Gamma-tocopherol (Vitamin E) at Day 7 From Day 0.	7.30 microM Standard Error 0.98	-0.10 microM Standard Error 0.21	7.28 microM Standard Error 1.57	-0.24 microM Standard Error 0.13

SECONDARY outcome

Timeframe: Day 0 and 7 of intervention

Plasma measurements of malondialdehyde, a marker of lipid peroxidation was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation

Outcome measures

Outcome measures
Measure	Dietary Supplement + Smoking Cessation n=14 Participants Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids	Placebo + Smoking Cessation n=16 Participants Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids	Dietary Supplement + Nicotine Replacement Therapy n=13 Participants Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy	Placebo + Nicotine Replacement Therapy n=13 Participants Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
Absolute Change From Baseline in Plasma Malondialdehyde at Day 7 From Day 0.	-0.08 microM Standard Error 0.05	-0.06 microM Standard Error 0.03	-0.04 microM Standard Error 0.04	-0.07 microM Standard Error 0.02

Adverse Events

Dietary Supplement + Smoking Cessation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo + Smoking Cessation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dietary Supplement + Nicotine Replacement Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo + Nicotine Replacement Therapy

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

Richard Bruno, PhD, RD

Ohio State University

Phone: 614-292-5522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place