Table 1.
Overview of the four included trials
| NU‐AGE (n = 1296) | ProMO (n = 82) | ProMuscle (n = 127) | PiP (n = 168) | |
|---|---|---|---|---|
| Trial registration number a | NCT01754012 | NCT02683720 | NTR6038 | |
| Years of enrolment | 2012–2014 | 2016–2017 | 2009–2010 | 2016–2018 |
| Inclusion criteria | 65–79 years | ≥65 years; Undernutrition (MNA‐SF score <12) | ≥65 years; frail or pre‐frail according to Fried criteria | ≥65 years; frail or pre‐frail according to Fried criteria or physical inactive and experiencing difficulties in daily activities |
| Exclusion criteria | Frail according to Fried criteria; malnutrition; dementia; major chronic diseases; severe heart disease; insulin‐treated diabetes | Resistance exercise >2 h/week; life expectancy <12 months; eGFR <30 mL min−1 (1.73 m2)−1; use of diabetes medication; use of >21 alcohol units per week | Participation in resistance‐type exercise programmes in 2 years prior to study; eGFR <60 mL min−1 (1.73 m2)−1; any present form of cancer; COPD; diabetes | Recent surgery (<3 months); receiving terminal care; eGFR <30 mL min−1 (1.73 m2)−1; any present form of cancer; COPD; unregulated diabetes or hypertension |
| Dietary assessment | 7‐day food records | 2‐day food records | 3‐day food records | 3‐day food records |
| BMD assessment | DXA (Lunar Prodigy, Lunar iDXA, Discovery Wi, Discovery QDR) | DXA (Lunar Prodigy Advance) | DXA (Lunar Prodigy Advance) | DXA (Lunar Prodigy Advance) |
| Intervention | Two arms: dietary intervention based on dietary recommendations for older adults and a vitamin D supplement (10 μg/d) versus control | Two arms: supplementation with A (24 g casein, 4 μg vitamin D, 364 mg calcium), or B (11 g casein, 11 g whey, 7 g free BCAA, 11 μg vitamin D, 296 mg calcium) | Four arms: supplementation with 31 g of milk protein concentrate or placebo, with or without resistance exercise training | Two arms: increased protein intake of 25 g per main meal via conventional and enriched products in combination with resistance exercise training versus control |
| Duration | 1 year | 12 weeks | 24 weeks | 24 weeks |
| Primary outcome | C‐reactive protein | Lean body mass | Lean body mass | Short Physical Performance Battery |
BCAA, branched‐chain amino acids; BMD, bone mineral density; COPD, chronic obstructive pulmonary disease; eGFR, estimated glomerular filtration rate; MNA‐SF, Mini Nutritional Assessment Short Form; NU‐AGE, New dietary strategies addressing the specific needs of elderly population for healthy ageing in Europe; PiP, ProMuscle in Practice; ProMO, Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly; ProMuscle, Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People.
a
Trial registration numbers starting with NCT are registered at clinicaltrials.gov and numbers starting with NTR are registered at the Dutch Trial Register.