Effect of caloric restriction with probiotic supplementation on body composition, quality of life, and psychobiological factors of obese men: A randomized, double-blinded placebo-controlled clinical trial
Abstract
BACKGROUND & AIMS
Obesity is a chronic disease characterized by an excess of fat mass. It is accompanied by a low-grade chronic systemic inflammation state that leads to numerous health disorders. To counteract this scenario, dietary-derived caloric restriction (CR) is the principal intervention for weight loss. Furthermore, probiotic supplementation has gained attention as a co-intervention to optimize weight loss and other health-related factors. As such, we aimed to verify the effect of CR with probiotic supplementation on the body composition, quality of life, sleep quality, anxiety, stress, and depression symptoms of adult men living with obesity.
METHODS
The study is called the Clinical Study of Obesity and Intestinal Microbiota (ECOMI). It is a randomized, double-blind, placebo-controlled clinical trial involving two parallel groups of stable-weight adult men living with obesity. The inclusion criteria were male individuals aged 25-44 years, with body mass index (BMI) ranging from 30.0 to 39.99 kg/m2, and stable body mass over the preceding three months. Participants were randomly assigned to two groups: Caloric Restriction with Probiotic (CRPRO) and Caloric Restriction with Placebo (CRPLA). The achieved CR was 30 % of the total daily energy expenditure. Macronutrients were distributed as 50 % carbohydrates, 30 % lipids, and 20 % proteins. Probiotic supplementation was carried out using two sachets/day of 1 g, containing 1 × 109 Colony Forming Units (CFU) of each…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 13 participants or records.
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