Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses

gamma tocopherol 1400 mg, taken as 2 700 mg capsules every 12 hours for a total of 4 doses

Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks and then gamma tocopherol will be taken as 2 gel tabs (1200 mg/dose) every 12 hours for a total of 4 doses.

Placebo Then Gamma T

Gamma tocopherol will be taken 2 gel tabs (1200 mg/dose) every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks followed by safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses.

Gamma Tocopherol Then Placebo

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cells. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum percent neutrophils compared to placebo pre-treatment.

gamma tocopherol 1400 mg, taken as two 700 mg capsules every 12 hours for a total of 4 doses

Gamma Tocopherol (N=7)

Placebo (N=7)

Change From Baseline in Sputum Percent Neutrophils (%PMN) Following Ozone Exposure

The investigators assessed induced sputum cellularity at baseline and 6 hours after ozone exposure to determine if treatment with gamma tocopherol/placebo impacts ozone-induced sputum eosinophilia.

Change in Sputum Percent Eosinophils From Baseline Following Ozone Exposure

Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.

Gamma Tocopherol

Placebo

Change in Sputum Interleukin (IL)-1b From Baseline Following Ozone Exposure

Change in Sputum IL-6 From Baseline Following Ozone Exposure

Change in Sputum IL-8 From Baseline Following Ozone Exposure

Change in Sputum Tumor Necrosis Factor (TNF)-Alpha From Baseline Following Ozone Exposure

Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of sputum mucins to determine if gamma tocopherol pre-treatment reduces ozone-induced sputum mucins compared to placebo pre-treatment.

Change in Sputum Mucins From Baseline Following Ozone Exposure

Whole lung clearance was measured using gamma scintigraphy and represented as mean average 120 minute clearance of inhaled technetium (99mTc) sulfur colloid particles in order to estimate the rate of airway mucociliary clearance.

Change in Whole Lung Clearance of Technetium Sulfur Colloid Particles (0-120 Minutes) From Baseline Following Ozone Exposure

Central lung clearance (0-30 minutes) was measured using gamma scintigraphy and represented as mean average 30 minute clearance of inhaled technetium (99mTc) sulfur colloid particles from the large bronchial airways.

Change in Central Lung Clearance of Technetium Sulfur Colloid Particles (0-30 Minutes) From Baseline Following Ozone Exposure

Participants first received safflower oil, taken in two 700 mg capsules every 12 hours for a total of 4 doses followed by a washout period of at least 3 weeks. Then they received gamma tocopherol-enriched supplement taken in two 700 mg capsules (total of 1200 mg of gamma tocopherol) every 12 hours for a total of 4 doses.

Participants first received gamma tocopherol-enriched supplement taken in two 700 mg capsules (total of 1200 mg of gamma tocopherol) every 12 hours for a total of 4 doses, followed by a washout period of at least 3 weeks. They then received safflower oil, taken in two 700 mg capsules every 12 hours for a total of 4 doses.

First Intervention

Washout

Second Intervention

Carole Robinette Assistant Director of Clinical Research

Allergic Asthma

The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after γT dosing.

gamma tocopherol

The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after placebo dosing.

Center for Environmental Medicine, Asthma and Lung Biology

Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure

University of North Carolina, Chapel Hill

National Institute of Environmental Health Sciences (NIEHS)

Healthy

Following a 28-day washout one 250ml drink / day containing 8g of agar H1CC2013 as part of normal diet for 28 days

Agar H1CC2013

Following a 28-day washout one 250ml drink / day containing 8g of agar H1CC2012 as part of normal diet for 28 days

Agar H1CC2012

Following a 28-day washout one 250ml drink / day containing 8g of maltodextrin as part of normal diet for 28 days

Maltodextrin

Hydrocolloids as Functional Food Ingredients for Gut Health

Faecal sample type by inspection (Bristol Stool Chart)

Food diary analysed using a Food Composition Database

Oral glucose tolerance test following 1.Glucose + Alginate H1CC2012, or 2. Glucose

University of Ulster

CyberColloids Ltd.

University of Reading

The Hebridean Seaweed Company

Marigot Ltd.

Industrias Roko, S.A.

The intervention to be administered is:
a commercially available gel that contains carrageenan.
water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the placebo gel.
also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.

The intervention to be administered is:
a commercially available gel that does not contain carrageenan.
water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the carrageenan-containing gel.
also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.

Human Papillomavirus Infection

Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.

Carrageenan-based gel

Control gel

McGill University - Division of Cancer Epidemiology

Lubricant Investigation in Men to Inhibit Transmission of HPV Infection

A Randomized Controlled Trial of a Carrageenan-Containing Lubricant to Reduce Transmission of Human Papillomavirus Infection Among Men Who Have Sex With Men

Detection of 36 different HPV types will allow for the assessment of new HPV types even among those already infected.

Measured via questionnaires and review of patient adverse event reports.

Dr. Eduardo Franco

James McGill Professor and Chair (Department of Oncology) and Director (Division of Cancer Epidemiology)

McGill University

Université de Montréal

Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days, washout for minimum 3 weeks, then Safflower oil capsules x 14 days

Gamma Tocopherol (14 Days) Then Placebo (14 Days)

Safflower oil capsules x 14 days, washout for minimum 3 weeks, then Gamma Tocopherol (2 capsules, each containing 700 mg, daily) x 14 days

Placebo (14 Days) Then Gamma Tocopherol (14 Days)

Atopy

Body Mass Index (BMI)

Forced expiratory volume in 1 second (FEV1) (%predicted)

In asthmatic individuals, exposure to CCRE is expected to increase PMNs in the sputum. The sputum PMNs were measured at baseline (immediately prior to dosing) and again on day 14 of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare the change in PMNs from baseline to post treatment after exposure to CCRE

Gamma Tocopherol 700 mg capsules,: 2 capsules daily for 14 days

700 mg Safflower oil capsules; 2 capsules daily for 14 days

Comparison of Change in Sputum Percent Neutrophils (PMN)s Following Inhaled Clinical Center Reference Endotoxin (CCRE) Challenge as Affected by Gamma Tocopherol

The sputum eosinophils were measured at baseline (immediately prior to dosing) and again after 14 days of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare sputum eosinophils per mg before and after gamma tocopherol treatment.

Chronic Eosinophilic Airway Inflammation as Affected by Gamma Tocopherol

On day 14 of treatment (approximately 6 hours after the final dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period.

Gamma Tocopherol 700 mg capsules: 2 capsules daily for 14 days

Mucociliary Clearance (MCC) Associated With CCRE Challenge as Affected by Gamma Tocopherol

On day 11 of treatment (approximately 6 hours after the daily dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period.

Mucociliary Clearance as Affected by Gamma Tocopherol

First Intervention (14 Days)

Washout (Minimum 3 Weeks)

Second Intervention (14 Days)

Allison Burbank, MD

Gamma Tocopherol 700 mg capsules; 2 capsules daily for 14 days

Mild, Allergic Asthma

Gamma Tocopherol 700 mg capsules,

Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled LPS

Purdue University

Schizophrenia

Shiatsu treatment provided in 40-minute sessions, twice a week for 4 weeks

carrageenan/neoplasms

Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure

Hydrocolloids as Functional Food Ingredients for Gut Health

Lubricant Investigation in Men to Inhibit Transmission of HPV Infection

Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled LPS

Shiatsu Adjuvant Therapy For Schizophrenia

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