Trial reportAging clinical and experimental research2020
Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults.
Trial report in Aging clinical and experimental research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- How Pragmatic Are Sarcopenia Intervention Studies? A Systematic Review.Journal of cachexia, sarcopenia and muscle · 2026Pooled it
- The Impact of Whey Protein Supplementation on Sarcopenia Progression among the Elderly: A Systematic Review and Meta-Analysis.Nutrients · 2023Pooled it
- Vitamin D Supplementation Improves Handgrip Strength in Postmenopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Frontiers in endocrinology · 2022Pooled it
- The effect of 12-weeks Nutritional supplementation on Nutritional Intake and Status among Indonesian Older Outpatients with Malnutrition Risk, the Prolansia study: a randomized controlled trial.The journal of nutrition, health & aging · 2025Trial
- Leucine-enriched whey protein supplementation, resistance-based exercise, and cardiometabolic health in older adults: a randomized controlled trial.Journal of cachexia, sarcopenia and muscle · 2021Trial
- Whey Proteins and Metabolic Dysfunction-Associated Steatotic Liver Disease Features: Evolving the Current Knowledge and Future Trends.Metabolites · 2025Review
- Observational
- Review
- Investigating the Health Implications of Whey Protein Consumption: A Narrative Review of Risks, Adverse Effects, and Associated Health Issues.Healthcare (Basel, Switzerland) · 2024Review
- The nutritional support to prevent sarcopenia in the elderly.Frontiers in nutrition · 2024Review
- Benefits and side effects of protein supplementation and exercise in sarcopenic obesity: A scoping review.Nutrition journal · 2023Article
- Measuring health-related quality of life in sarcopenia: summary of the SarQoL psychometric properties.Aging clinical and experimental research · 2023Review
- A multi-center prospective study of plant-based nutritional support in adult community-based patients at risk of disease-related malnutrition.Frontiers in nutrition · 2023Article
- Whey Protein, Leucine- and Vitamin-D-Enriched Oral Nutritional Supplementation for the Treatment of Sarcopenia.Nutrients · 2022Review
- Nutrition and sarcopenia: Current knowledge domain and emerging trends.Frontiers in medicine · 2022Article
- The Optimal Strategy of Vitamin D for Sarcopenia: A Network Meta-Analysis of Randomized Controlled Trials.Nutrients · 2021Article
- Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults.Aging clinical and experimental research · 2021Review
- Editorial: COVID-19 - The Long Road to Recovery.The journal of nutrition, health & aging · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 11 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsSafety and tolerability of prolonged supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink (WP-MND) was evaluated in sarcopenic older adults.
methodsA 13-week double-blinded, randomized, isocaloric placebo-controlled trial (PROVIDE study; n = 380) was extended with a voluntary 13-week open-label extension (OLE). OLE participants were randomized to receive daily 1 or 2 servings of WP-MND (21 g protein, 3 g leucine, 10 µg vitD and 500 mg calcium per serving). Gastro-intestinal tolerability, kidney function and serum levels of calcidiol, parathyroid hormone (PTH) and calcium were evaluated at week 0, 13 and 26. RESULTS AND DISCUSSION: In response to the high daily protein intake (median1.5; IQR: 1.3, 1.7 g/kg BW/day), the estimated glomerular filtration rate (eGFR) increased in the test group during the RCT (p = 0.013). The same trend was observed for those participants with moderate chronic kidney disease. During OLE no eGFR change was observed in any of the groups. Serum calcidiol and calcium reached a plateau after 13-week WP-MND supplementation. As expected, PTH significantly changed in the opposite direction, decreasing during RCT in the test group (T vs C: p < 0.001) and during OLE in former control groups. During RCT, 20/366 participants with normal baseline calcidiol reached levels ≥ 100 nmol/L (T: n = 18; C: n = 2) and 6 developed albumin-corrected calcium levels > 2.55 mmol/L (T: n = 3; C: n = 3), without associated adverse events.
conclusionA 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity. The product was overall well tolerated.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.