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Minimal nutrition intervention with high-protein/low-carbohydrate and low-fat, nutrient-dense food supplement improves body composition and exercise benefits in overweight adults: a randomized controlled trial
Lockwood CM, Moon JR, Tobkin SE, Walter AA, Smith AE, Dalbo VJ, Cramer JT, Stout JR
Nutrition & Metabolism 2008 Apr 21;5(11):Epub
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Exercise and high-protein/reduced-carbohydrate and -fat diets have each been shown separately, or in combination with an energy-restricted diet to improve body composition and health in sedentary, overweight (BMI > 25) adults. The current study, instead, examined the physiological response to 10 weeks of combined aerobic and resistance exercise (EX) versus exercise plus minimal nutrition intervention designed to alter the macronutrient profile, in the absence of energy restriction, using a commercially available high-protein/low-carbohydrate and low-fat, nutrient-dense food supplement (EXFS); versus control (CON). METHODS: Thirty-eight previously sedentary, overweight subjects (female = 19; male = 19) were randomly assigned to either CON (n = 10), EX (n = 14) or EXFS (n = 14). EX and EXFS participated in supervised resistance and endurance training (2x and 3x/wk, respectively); EXFS consumed 1 shake/d (weeks 1 and 2) and 2 shakes/d (weeks 3 to 10). RESULTS: EXFS significantly decreased total energy, carbohydrate and fat intake (-14.4%, -27.2% and -26.7%, respectively; p < 0.017), and increased protein and fiber intake (+52.1% and +21.2%, respectively; p < 0.017). EX and EXFS significantly decreased fat mass (-4.6% and -9.3%, respectively; p < 0.017), with a greater (p < 0.05) decrease in EXFS than EX and CON. Muscle mass increase only reached significance in EXFS (+2.3%; p < 0.017), which was greater (p < 0.05) than CON but not EX (+1.1%). Relative VO2max improved in both exercise groups (EX = +5.0% and EXFS = +7.9%; p < 0.017); however, only EXFS significantly improved absolute VO2max (+6.2%; p = 0.001). Time-to-exhaustion during treadmill testing increased in EX (+9.8%) but was significantly less (p < 0.05) than in EXFS (+21.2%). Total cholesterol and LDL decreased only in the EXFS (-12.0% and -13.3%, respectively; p < 0.017). Total cholesterol-to-HDL ratio, however, decreased significantly (p < 0.017) in both exercise groups. CONCLUSION: Absent energy restriction or other dietary controls, provision of a high-protein/low-carbohydrate and -fat, nutrient-dense food supplement significantly, (1) modified ad libitum macronutrient and energy intake (behavior effect), (2) improved physiological adaptations to exercise (metabolic advantage), and (3) reduced the variability of individual responses for fat mass, muscle mass and time-to-exhaustion -- all three variables improving in 100% of EXFS subjects.

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