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Articles

A Randomized Double-Blind, Placebo Controlled, Four-Arm Parallel Study Investigating the Effect of a Broad-Spectrum Wellness Beverage on Mood State in Healthy, Moderately Stressed Adults

, DVM, PhD, , PhD, , BSc, , MBA & , MBA, PhD, DSc, FACN
Pages 234-242 | Received 28 Aug 2017, Accepted 13 Oct 2017, Published online: 09 Jan 2018

Figures & data

Figure 1. Schematic representation of the study design.

Figure 1. Schematic representation of the study design.

Table 1. Demographics and characteristics of all randomized participants at screening (numbers and percentages; mean values with their standard errors).

Figure 2. Disposition of study participants. A total of 121 potential participants were screened and 99 eligible participants were enrolled in the study (with 25 participants in each study group, except for 1-dose Zeal Wellness, which had 24). Ninety-four participants completed the study. Fifteen participants were removed from the per protocol (PP) analysis; nine participants had missing Profile of Mood States, two participants were noncompliant, one participant had low compliance, two participants withdrew from the study because of an adverse event, and one participant requested to be removed from the study. ITT = intent-to-treat.

Figure 2. Disposition of study participants. A total of 121 potential participants were screened and 99 eligible participants were enrolled in the study (with 25 participants in each study group, except for 1-dose Zeal Wellness, which had 24). Ninety-four participants completed the study. Fifteen participants were removed from the per protocol (PP) analysis; nine participants had missing Profile of Mood States, two participants were noncompliant, one participant had low compliance, two participants withdrew from the study because of an adverse event, and one participant requested to be removed from the study. ITT = intent-to-treat.

Figure 3. Total mood disturbance score results at days 0, 8, 15, and 29 for participants receiving supplementation with Zeal Wellness 1/day, Zeal Wellness 2/day, and placebo (N = 99). POMS = Profile of Mood States.

Figure 3. Total mood disturbance score results at days 0, 8, 15, and 29 for participants receiving supplementation with Zeal Wellness 1/day, Zeal Wellness 2/day, and placebo (N = 99). POMS = Profile of Mood States.

Figure 4. Anger-hostility score results at days 0, 8, 15, and 29 for participants receiving supplementation with Zeal Wellness 1/day, Zeal Wellness 2/day, and placebo (N = 99). POMS = Profile of Mood States.

Figure 4. Anger-hostility score results at days 0, 8, 15, and 29 for participants receiving supplementation with Zeal Wellness 1/day, Zeal Wellness 2/day, and placebo (N = 99). POMS = Profile of Mood States.

Figure 5. Profile of Mood States (POMS) t-score iceberg profile at day 0 and day 29 for participants receiving supplementation with Zeal Wellness 1/day, Zeal Wellness 2/day, and placebo (N = 99).

Figure 5. Profile of Mood States (POMS) t-score iceberg profile at day 0 and day 29 for participants receiving supplementation with Zeal Wellness 1/day, Zeal Wellness 2/day, and placebo (N = 99).