CLINICAL STUDY

CLINICAL STUDY

Table of Contents

ABSTRACT2

INTRODUCTION2

METHODS3

Clinical trial participants3

Sample size calculation3

RESULTS4

DISCUSSION5

ABSTRACT

Our supplement is a natural health product marketed as energy-enhancing; however, no objective data substantiate this claim. The study objective was to determine if ingestion of supplements. decreases the incidence of colds and flu in an otherwise healthy populations. A total of 26 people were enrolled in this randomized, double-blind, placebo-controlled clinical trial; divided into 2 groups with 13 people in each. Both treatment and placebo groups showed a significant time trend effect, scoring better on all outcome measures as the trial progressed. Compared with the placebo group, the our supplement group scored marginally higher on vitality, the primary outcome measure (p = 0.055), and significantly higher on energy (a secondary outcome measure, p = 0.018). Findings were based on repeated measures analysis of variance; baseline scores were used as covariates. Although a trend toward greater improvement in our supplement group was noted in the other secondary outcome measures, this trend did not reach statistical significance. Overall, our findings were positive but not conclusive that Our supplement increases vitality and energy. These results provide justification for further study of the effects of supplements.

INTRODUCTION

Limited evidence is available to support the inclusion of each individual ingredient in a product purported to increase energy and immune function. For example, spirulina has often been advertised as an "energy booster"; however, no evidence to support this claim could be found m the scientific literature. Green tea contains caffeine and other compounds identified as having stimulatory activity, but whether the quantity present in our supplement will have any clinically relevant effects is unclear. Several clinical studies designed to assess whether Siberian ginseng enhances humans' ability to withstand adverse conditions, quality of work under stressful conditions, athletic performance, and mental alertness have been inconclusive. Although some in vitro and animal studies suggest that certain our supplement ingredients (e.g., royal jelly, bee pollen, and Siberian ginseng may have immune modulating effects, whether the amounts in the product will have any clinical effects in humans is unclear.

Despite the potential of our supplement it has never been rigorously studied in clinical trials. The study objective was to determine if daily ingestion of 15 mL of our supplement mixed in 250 mL of apple juice decreases the incidence of cold and flues in an otherwise healthy adult population.

METHODS

This was a prospective, randomized, double-blind, placebo-controlled clinical trial (10,11). Through the use of a random number table, participants were assigned to treatment or control groups when they provided informed consent. Neither the participants nor the research staff knew which product (Our supplement or placebo) participants received throughout the study. The study product and placebo powder were packaged m identical bottles, sealed by the manufacturer, and labeled only with a study code and directions for use.

Clinical trial participants

Participants under 55 who had never taken a herbal our supplement product were recruited. Recruitment was from the greater area and conducted through newspaper advertisements. The study was restricted to these groups because they appear to be ...