Randomized Controlled Trial of A 12-Week Yoga-Based (Including Diet) Lifestyle vs. Dietary Intervention on Cardio-Metabolic Risk Factors and Continuous Risk Score in Indian Adults with Metabolic Syndrome

Abstract

Metabolic syndrome, a prediabetic and precardiovascular pathologic condition that begins early in life, tracks into adulthood and magnifies with age. Randomized controlled trials evaluating efficacy of yoga-based lifestyle vs. dietary intervention on metabolic syndrome are lacking. Here, the efficacy of a 12-week yoga-based lifestyle intervention vs. dietary intervention on cardio-metabolic risk factors and metabolic syndrome risk scores have been assessed in Indian adults with metabolic syndrome. In this two-arm, open label, parallel group, randomized controlled trial, 260 adults (20–45 years) diagnosed with metabolic syndrome as per joint interim statement, 2009 were randomized to yoga-based (including diet) lifestyle or dietary intervention alone (n = 130, each) for 12 weeks. Primary endpoints were the 12-week changes in cardio-metabolic risk factors and metabolic risk scores. The secondary endpoints were the 12-week changes in the proportion of subjects recovered from metabolic syndrome, dietary intake, and physical activity. Intent-to-treat analysis was performed including all the subjects with baseline data with imputed missing data. Treatment × time interaction showed yoga-based lifestyle intervention had a greater treatment effect over dietary intervention by significantly reducing waist circumference, continuous metabolic syndrome z-score, and dietary intake/day while significantly increasing physical activity. High-density lipoprotein cholesterol showed a significantly greater reduction following dietary intervention than yoga-based lifestyle intervention. A significantly greater proportion of subjects recovered from metabolic syndrome in yoga-based lifestyle (45.4%) vs. dietary intervention group (32.3%). A 12-week yoga-based lifestyle intervention is more efficacious than usual dietary intervention in improving cardio-metabolic risk factor and metabolic risk score in Indian adults with metabolic syndrome.

Keywords:

• Dietary intervention
• metabolic syndrome
• risk
• yoga-based lifestyle intervention
• Z-score

Acknowledgements

Authors are thankful to the subjects who volunteered to participate in this trial. Authors also extend their sincere thanks to Amit Tomar (Yoga therapist), Pragati Pragya (Dietician) for their constant help and support. Authors gratefully acknowledge and thank Central Council for Research in Yoga and Naturopathy (CCRYN), Department of AYUSH, Government of India for funding the research and Department of Physiology, AIIMS, New Delhi for providing financial support for the study.

Ethical standards

All procedures, including the informed consent process, were conducted in accordance with the ethical standards of the responsible committee on human experimentation institutional and with the Helsinki Declaration of 1975, as revised in 2000. All patients included in the analysis provided informed consent for their data to be used in research. Ethical approval was provided by the All India Institute of Medical Sciences, New Delhi Ethics Committee (IESC/T-137/30.03.2012, RT-04/2012).