The Physiology Of the WEight Reduced State (POWERS) study: strategies for the analysis of biological specimens

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Abstract The Physiology Of the WEight Reduced State (POWERS) study is a multi-center clinical trial designed to understand the physiological basis for observed variability in weight regain following intentional weight loss among US adults. The primary dependent variable is weight regain over one year following a 7% or greater supervised weight loss. The overarching design and study organization, along with rationale and history of the POWERS study and outcomes measures are described in accompanying papers. This paper provides the rationale for and description of biospecimens samples that will ultimately inform on the molecular and cellular basis of the physiological variability that contributes to the regulation of energy balance in the weight reduced state. Participants will be 205 healthy adults ( n = 205), aged 25–59 years, with body mass index (BMI) 30- ≤ 40 kg/m 2 . Biospecimens will be collected prior to weight loss (baseline, BL), immediately following weight loss via lifestyle intervention (T0), and then four (T4) and twelve (T12) months after weight loss. Blood will be collected in the fasting state and following a meal challenge designed to induce hormones related to satiety. Weight change from T0 to T12 will be the primary outcome variable. Biospecimens to be collected include plasma, serum, peripheral blood mononuclear cells (PBMCs), DNA, urine, feces, adipose and skeletal muscle tissue. All samples will be biobanked at each site. This manuscript describes the rationale for the biospecimens chosen to assess contributors to homeostatic mechanisms that drive observed variability of weight regain after weight loss.

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