A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial

Randomized controlled trial in healthy older men from Canada, all non-diabetic at screening. The active group had a mean age of 71 ± 1 years and baseline BMI of 28.9 ± 0.8 kg/m2. The study compared the supplement with a matched control over 20 weeks, with an initial supplementation-only period followed by a 12-week supervised exercise phase.

Participants in the active arm consumed two drinks daily for 20 weeks. Each drink contained whey protein 30 g, creatine 2.5 g, calcium 400 mg, vitamin D 500 IU, carbohydrate 1 g, and 116 kcal; the morning serving also included an oil preparation providing 3000 mg n-3 PUFA, including EPA 1400 mg and DHA 890 mg. The control drink and oil were matched for flavor and odor; the control oil was safflower oil.

Twice-daily supplementation increased lean mass and strength in healthy older men, and adding structured exercise further enhanced strength gains, especially for the upper body. During weeks 0-6, isotonic strength increased by +14 ± 4 kg with the supplement versus +3 ± 2 kg with control (P < 0.001), and lean body mass increased by +1.2 ± 0.3 kg versus -0.1 ± 0.2 kg (P < 0.001). By the end of the study, upper body strength was 119 ± 4 kg in the supplement group versus 109 ± 5 kg in controls (P = 0.039). There were significant group-by-time interactions for whole body lean mass (P < 0.01), appendicular lean mass (P = 0.021), leg lean mass (P = 0.015), and trunk lean mass (P < 0.01).

The trial enrolled only healthy older men, limiting generalizability to women, younger adults, or clinical populations. The intervention combined several active ingredients, so the effects of individual components cannot be separated. Ethnicity was not reported, and adverse-event data were not provided in the extracted source.