This research protocol was approved by a university internal review board for the protection of human participants prior to initiation. Participants were recruited from local newspapers, radio advertisements, flyers, and the Internet. Participants meeting eligibility criteria attended a familiarization session. Entrance criteria stipulated recruitment of sedentary females between the ages of 60–75 years with a body mass index (BMI) greater than 27 kg/m2 and/or body fat percentage above 35% and no recent participation in a diet or exercise program or weight loss within the previous six months. Participants obtained medical clearance from their family physician prior to participating in baseline assessments. Exclusion criteria included: (1) presence of uncontrolled metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, or thyroid disease; (2) history of hypertension or hepatorenal, musculoskeletal, autoimmune, or neurological diseases; (3) current prescription of thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications; or (4) consumption of ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, β-Hydroxy β-methylbutyric acid, anabolic/catabolic hormone levels (e.g., dehydroepiandrosterone), or weight loss (e.g., thermogenics) within the three months prior to the start of the study.
Figure 1 presents a consolidated standards of reporting trials (CONSORT) diagram. A total of 72 women met the entrance criteria, completed baseline testing, and began the exercise and/or diet program intervention. Fifteen participants withdrew during the first month citing a lack of desire to continue. One participant had recurrent musculoskeletal complaints unrelated to the intervention and was dropped during the second month. One participant was dropped for medical reasons during the last week of the study due to recurrent symptoms of hypotension n, and one participant was dropped due to failure to comply with dietary instructions and/or training compliance. Therefore, a total of 54 volunteers completed the 14-week intervention and were included in the analysis. This included 17 participants in the higher protein (HP) group, 18 participants the higher carbohydrate group (HC), and 19 participants in the exercise-only (E) group.
Consolidated standards of reporting trials (CONSORT) flow chart.
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