Choudhary D, Bhattacharyya S, Joshi K. Body weight management in adults under chronic stress through treatment with Ashwagandha root extract: a double-blind, randomized, placebo-controlled trial. J Evid Based Complementary Altern Med. 2016 Apr 6. pii: 2156587216641830. [Epub ahead of print]
The objective of this 8-week double-blind, randomized, placebo-controlled trial was to evaluate the safety and efficacy of a standardized extract of Ashwagandha for controlling weight and improving general well-being in adults with chronic stress. At baseline and at the end of 4 weeks and 8 weeks, individuals were assessed for the primary outcome measures listed below.
Individuals were selected from several outpatient clinics in Pune, India, for the purpose of addressing stress and overweight. Inclusion criteria included chronic/routine work stress, a Perceived Stress Scale (PSS) of 20 or more, age between 18 and 60 years, and a body mass index between 25 and 39.9 kg/m2. Exclusion criteria included eating disorders; participation in a weight loss program during the previous 3 months; and endocrine or genetic condition that predisposes to weight gain; a neurologic disorder; any unstable medical condition; known allergy/side effects to Ashwagandha root extract; pregnancy or lactation; medications that affect weight; participation in another clinical trial in the previous 3 months; history of alcohol abuse or smoking; and unstable hepatic, renal, cardiovascular or respiratory disease.
The majority of the individuals in both groups were employed (72% Ashwagandha; 68% placebo). The others were identified as either students or housewives. All individuals had chronic stress symptoms, and the majority had difficulties with concentration and insomnia. About 44% of the Ashwagandha group and 52% of the placebo group had problems with anxiety and restlessness. Other significant symptoms included physical exhaustion, mental fatigue, and headaches.
A total of 38 men and 14 women were enrolled in the study and randomized to either group. One from each group was noncompliant with the protocol. Data for the remaining 50 were then evaluated.
Individuals were given either a standardized extract of Ashwagandha root extract (300 mg, containing 5% withanolides) or placebo twice per day for 8 weeks.
Primary Outcome Measures
The primary outcome measures were the PSS and the Food Cravings Questionnaire-Trait (FCQ-T). Secondary outcome measures included the Oxford Happiness Questionnaire (OHQ), the Three-Factor Eating Questionnaire (TFEQ), serum cortisol levels, initial and final body weight, and BMI. The PSS, a measure of psychological stress, is a 14-item scale that determines general stress experienced in the previous month. Scores range from 0 to 56, with higher scores representing higher stress. The PSS evaluates physical and mental symptoms of depression, the requirement for health services, social anxiety, and life event scores that correlate. The FCQ-T is a 39-item, self-reported questionnaire used to measure food cravings in 9 domains. The QHQ consists of 29 questions that measure happiness, well-being, and optimism. Serum cortisol levels are an indicator of stress and are also associated with appetite. In this study, cortisol represents a measurement of the antistress effect of Ashwagandha in those individuals under chronic stress. The TFEQ questionnaire is used to determine eating behavior and assess cognitive restraint, uncontrolled eating, and emotional eating.
The mean PSS score decreased in both the treatment and placebo groups, but the treatment group experienced a significantly greater reduction in PSS scores than the placebo group at week 4 and even more so at week 8. The mean FCQ “planning score” was lower in both groups but was significantly lower in the treatment group than the placebo group at the end of week 4 and 8. The FCQ “positive reinforcement” score at week 8 was significantly lower in the treatment group than that of the placebo group. The mean FCQ “negative reinforcement” scores of the treatment group did not show any significant difference compared to placebo at week 4 or 8. Lastly, the mean FCQ sores showed a significant reduction from baseline and compared to placebo for lack of control, emotion, and environment, although the thoughts about food, physiological, and guilt components did not show any significant differences compared to placebo.
Of the secondary outcomes, the serum cortisol and weight loss ones are most interesting from a clinician’s perspective. Mean serum cortisol levels, which had been equal in both groups at baseline, were reduced to a significantly greater degree in the treatment group at week 4 (16.05%) and week 8 (22.2%). After 8 weeks, the Ashwagandha group had a greater reduction in body weight compared to the placebo group (3.03% versus 1.46%).
As a quick summary, after 8 weeks, Ashwagandha was more effective than placebo in reducing PSS, several aspects of food cravings (although not thoughts about food or guilt about food), and uncontrolled and emotional eating (but not cognitive restraint). Reductions in body weight, BMI, and serum cortisol were also observed in these stressed individuals who took Ashwagandha standardized to 5% withanolides and 300 mg twice per day for 8 weeks. Previous research, and decades of observations from users and prescribers of Ashwagandha, strongly support its antistress and antianxiety therapeutic influence. The results of the current study punctuate these reports and observations and take the evaluation several steps further, with the added feature of weight loss in those living with chronic stress. From this study, we can add to our body of previous knowledge about Ashwagandha and confirm its ability to reduce psychological and physiological markers of stress, improve well-being, reduce serum cortisol, reduce food cravings, improve eating behaviors, and promote weight management in men and women under chronic stress. Longer-term studies would provide further insight.