Creatine + Whey Protein for Sarcopenia

Overseen By Darren Candow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Must not be taking: Creatine, Whey protein

Disqualifiers: Allergies to latex, dairy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 20 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this research is to compare the effects of creatine monohydrate and/or whey protein supplementation during the first 10 weeks of a 20-week resistance-band training program on measures of body composition (whole-body lean tissue mass, total body water), arm and leg muscle thickness, upper- and lower-body muscle performance (i.e., strength, endurance) and functional ability (walking speed, balance). A secondary purpose of this research is to examine the effects of supplementation cessation (i.e., no creatine and/or whey protein supplementation) during the final 10 weeks of the 20-week resistance-band training program on these measures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be taking creatine or whey protein before starting the study.

What data supports the effectiveness of the treatment Resistance-band Training combined with Creatine and Whey Protein for Sarcopenia?

Research shows that resistance exercise, like resistance-band training, helps increase muscle mass and strength in older adults with sarcopenia. Combining this exercise with whey protein and creatine can further enhance muscle growth and improve physical performance. ^{1 2 3 4 5}

Is creatine and whey protein safe for humans?

Whey protein is generally considered safe for humans, including older adults, and is often used to improve muscle health. It has been studied in various forms and combinations, showing benefits in muscle strength and function without significant safety concerns. ^{3 6 7 8 9}

How does the treatment of creatine and whey protein for sarcopenia differ from other treatments?

The combination of creatine and whey protein for sarcopenia is unique because it leverages both supplements' ability to enhance muscle mass and strength, especially when combined with resistance training. Creatine is known to boost muscle energy, while whey protein provides high-quality protein that supports muscle repair and growth, making this combination potentially more effective than using either supplement alone. ^{6 9 10 11 12}

Research Team

Darren Candow

Principal Investigator

University of Regina

Eligibility Criteria

This trial is for individuals with sarcopenia, a condition characterized by loss of muscle mass and strength. Participants should be interested in undergoing a 20-week resistance-band training program and are willing to take creatine monohydrate and/or whey protein supplements.

Inclusion Criteria

Untrained individuals (defined as those performing ≤ 1 resistance training session per week for ≥ 6 weeks prior to the start of the study)

Exclusion Criteria

Having pre-existing allergies to latex, fruit, dairy, nuts, seafood, and mustard

Currently ingesting whey protein

I have not taken creatine monohydrate in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 20-week resistance-band training program with creatine and/or whey protein supplementation during the first 10 weeks

20 weeks

Baseline, week 10, week 20 assessments

Supplementation Cessation

Participants cease creatine and/or whey protein supplementation during the final 10 weeks of the resistance-band training program

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after the training program

4 weeks

Treatment Details

Interventions

• Resistance-band Training

Trial Overview The study aims to compare the effects of creatine monohydrate and whey protein supplementation on body composition, muscle thickness, strength, endurance, and functional ability during a resistance-band training program. It also looks at what happens when these supplements are stopped halfway through the program.

Participant Groups

Group I: Whey Protein Experimental Treatment 1 Intervention

Group II: Creatine Whey Protein Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Iovate Health Sciences International Inc

Industry Sponsor

Trials

10

Recruited

350+

Findings from Research

Resistance exercise training is effective in combating sarcopenia in older adults, especially when combined with a diet that includes high-quality protein above the recommended intake of 0.8 g/kg/day.

Research indicates that protein-enriched supplements do not significantly enhance the benefits of resistance training if individuals are already consuming sufficient dietary protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic use of higher-protein diets or nutritional supplements with resistance training to counter sarcopenia. Campbell, WW.[2019]

Sarcopenia, the age-related loss of muscle mass, negatively impacts strength and quality of life, but resistance exercise can help increase muscle mass and strength in older adults.

Nutritional interventions, including essential amino acids, milk-based proteins, creatine monohydrate, essential fatty acids, and vitamin D, may enhance the benefits of resistance exercise on aging muscle biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nutritional interventions and resistance exercise on aging muscle mass and strength. Candow, DG., Forbes, SC., Little, JP., et al.[2013]

In an 8-week study with 12 elderly participants, a meal replacement formula containing essential amino acids (EAAMR) led to a greater reduction in adipose tissue compared to a competitive meal replacement, despite both groups losing about 7% of their total body weight.

While EAAMR did not significantly preserve lean tissue, it was associated with an increase in the skeletal muscle fractional synthesis rate (FSR), suggesting that it may help maintain muscle protein turnover during caloric restriction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey protein and essential amino acids promote the reduction of adipose tissue and increased muscle protein synthesis during caloric restriction-induced weight loss in elderly, obese individuals. Coker, RH., Miller, S., Schutzler, S., et al.[2022]

Whey protein supplementation during resistance exercise training (RET) in older adults with sarcopenia showed a small but significant increase in skeletal muscle mass and handgrip strength compared to RET without whey protein or with a placebo, based on a review of seven trials involving 591 participants.

Despite these positive findings, the overall effect sizes were small and did not exceed the minimally important clinical difference, indicating that while whey protein may help, the clinical significance of the improvements is limited and further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Whey Protein Supplementation during Resistance Exercise Training on Skeletal Muscle Mass and Strength in Older People with Sarcopenia: A Systematic Review and Meta-Analysis. Cuyul-Vásquez, I., Pezo-Navarrete, J., Vargas-Arriagada, C., et al.[2023]

Whey protein, leucine, and vitamin D supplementation significantly increased appendicular muscle mass in patients with sarcopenia, based on a meta-analysis of three studies involving 637 patients.

Combining these nutritional supplements with a physical exercise program led to significant improvements in muscle strength and function, as measured by handgrip strength and short physical performance battery (SPPB) scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Whey Protein, Leucine, and Vitamin D Supplementation in Patients with Sarcopenia: A Systematic Review and Meta-Analysis. Chang, MC., Choo, YJ.[2023]

Whey protein supplementation combined with resistance training significantly improves biceps curl strength and lower limb lean mass in postmenopausal women, based on a meta-analysis of 10 studies.

Without resistance training, whey protein does not provide significant benefits for muscle strength or lean mass, and it may even negatively impact dietary protein intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Whey Protein Supplementation in Postmenopausal Women: A Systematic Review and Meta-Analysis. Kuo, YY., Chang, HY., Huang, YC., et al.[2022]

Whey peptide (WP) supplementation significantly reduced fat mass and preserved lean mass in mice with sarcopenic obesity, regardless of whether they engaged in resistance exercise (RE).

WP supplementation improved energy metabolism in both adipose tissue and skeletal muscle, leading to reduced fat cell differentiation and decreased protein degradation and apoptosis, suggesting its potential as a treatment for sarcopenic obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Whey Peptide Supplementation on Sarcopenic Obesity in High-Fat Diet-Fed Mice. Lim, G., Lim, Y.[2023]

Whey protein supplementation alone did not significantly improve lean mass or muscle strength in older adults, but it did enhance physical function, particularly gait speed, in those with sarcopenia or frailty.

Co-supplementation of whey protein with vitamin D significantly improved lean mass, muscle strength, and physical function in older adults, suggesting that addressing vitamin D deficiency may enhance the benefits of protein supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey Protein Supplementation with or without Vitamin D on Sarcopenia-Related Measures: A Systematic Review and Meta-Analysis. Nasimi, N., Sohrabi, Z., Nunes, EA., et al.[2023]

Daily supplementation of 35 grams of whey protein may improve biomarkers associated with sarcopenia in older adults, suggesting it could be a beneficial dietary intervention for muscle health.

While whey protein enhances muscle signaling pathways, combining it with exercise provides the most significant benefits for maintaining muscle strength and mass in aging individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey for Sarcopenia; Can Whey Peptides, Hydrolysates or Proteins Play a Beneficial Role? Gilmartin, S., O'Brien, N., Giblin, L.[2020]

In a study involving resistance-trained males over 11 weeks, supplementation with whey protein and/or creatine significantly improved strength and muscle hypertrophy compared to a carbohydrate-only group.

The extent of muscle growth varied among the different supplement groups, indicating that while both whey protein and creatine can enhance strength and muscle size, their effects on muscle fiber types and contractile proteins differ, suggesting tailored approaches may be needed for different individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of whey isolate, creatine, and resistance training on muscle hypertrophy. Cribb, PJ., Williams, AD., Stathis, CG., et al.[2022]

In a 12-week study involving 26 older women with sarcopenic obesity, those who received 35g of whey protein daily alongside resistance training showed a significant increase in appendicular lean soft tissue (ALST) by 6.0% compared to only 2.5% in the placebo group.

The whey protein group also experienced a greater reduction in total fat mass (-3.3% vs. -0.3%) and trunk fat mass (-5.1% vs. -1.1%), indicating that whey protein supplementation can effectively improve body composition in older women with sarcopenic obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of whey protein supplementation combined with resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women with sarcopenic obesity: A randomized, double-blind, placebo-controlled trial. Nabuco, HCG., Tomeleri, CM., Fernandes, RR., et al.[2020]

A systematic review and meta-analysis of 357 older adults showed that combining creatine supplementation with resistance training significantly increased total body mass and fat-free mass compared to resistance training alone.

The addition of creatine also enhanced strength gains in exercises like the chest press and leg press, and improved functional performance in the 30-second chair stand test, indicating its potential benefits for healthy aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine supplementation during resistance training in older adults-a meta-analysis. Devries, MC., Phillips, SM.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Synergistic use of higher-protein diets or nutritional supplements with resistance training to counter sarcopenia. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of nutritional interventions and resistance exercise on aging muscle mass and strength. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Whey protein and essential amino acids promote the reduction of adipose tissue and increased muscle protein synthesis during caloric restriction-induced weight loss in elderly, obese individuals. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Whey Protein Supplementation during Resistance Exercise Training on Skeletal Muscle Mass and Strength in Older People with Sarcopenia: A Systematic Review and Meta-Analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Whey Protein, Leucine, and Vitamin D Supplementation in Patients with Sarcopenia: A Systematic Review and Meta-Analysis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Whey Protein Supplementation in Postmenopausal Women: A Systematic Review and Meta-Analysis. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Whey Peptide Supplementation on Sarcopenic Obesity in High-Fat Diet-Fed Mice. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Whey Protein Supplementation with or without Vitamin D on Sarcopenia-Related Measures: A Systematic Review and Meta-Analysis. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Whey for Sarcopenia; Can Whey Peptides, Hydrolysates or Proteins Play a Beneficial Role? [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of whey isolate, creatine, and resistance training on muscle hypertrophy. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Effect of whey protein supplementation combined with resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women with sarcopenic obesity: A randomized, double-blind, placebo-controlled trial. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Creatine supplementation during resistance training in older adults-a meta-analysis. [2018]