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A Randomized Double Blind Placebo Controlled Clinical Trial of Relora™ in the Management of Stress in Healthy Overweight Females
Author(s) -
Kalman Douglas,
Feldman Samantha,
Krieger Diane
Publication year - 2006
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.20.4.a379
Subject(s) - medicine , placebo , anxiety , randomized controlled trial , overweight , appetite , mood , placebo controlled study , physical therapy , body mass index , double blind , psychiatry , alternative medicine , pathology
This exploratory prospective randomized double blind placebo‐controlled clinical trial was conducted to assess the safety and efficacy of a proprietary blend of 2 plant extracts in reducing anxiety, salivary cortisol and food intake. The study enrolled healthy overweight physically active, 25–50‐year‐old women with anxiety who reported eating more in response to stressful situations. Subjects were randomized (1:1) to receive either placebo or 750 mg of Relora™, (Magnolia officinalis/Phellodendron amurense extracts) for 6 wks, with evaluations at baseline, mid‐ and end‐study. Efficacy variables included: mood & stress scores, cortisol levels, macronutrient intake, appetite, dietary restraint, & sleep ratings. Safety was assessed by changes in vital signs and biochemical laboratory tests. Of 40 validly‐enrolled subjects; 5 terminated early, & 9 were lost to follow‐up (8 PLA, 1 Relora). An intent‐to‐treat analysis indicated that the Spielberger Trait & Anxiety Index Total scores improved significantly, and by 2x as much with Relora as with PLA (p=0.047). Both groups showed significant decreases in Cohen PSS & PANAS scores, with PLA showing more improvement than Relora. Cortisol levels decreased in both groups at all times of day, but not significantly. No significant changes in appetite ratings, dietary restraint, or sleep quality were noted in either group. The Relora group had 2x as much average reduction in sleep latency (11 min, p=0.012) as the placebo group (5 min, p=0.147). Both groups showed significant decreases in macronutrient/caloric intake. No significant safety concerns or SAE’s were noted. Despite its modest sample size, this study demonstrates a significant improvement with Relora, relative to placebo, in several psychometric measures of stress.