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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how creatine and whey protein supplements can improve muscle and body strength when combined with a 20-week resistance-band workout program. Researchers aim to determine if these supplements affect muscle mass, strength, and daily activities like walking and balancing, particularly during the first 10 weeks. They also seek to understand the effects of discontinuing the supplements in the last 10 weeks. This trial suits individuals not currently engaged in significant weight training and without certain food allergies. As an unphased trial, it offers a unique opportunity to explore the potential benefits of supplements in enhancing daily life activities.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that creatine is a safe supplement for various groups, including older adults. Many well-controlled studies confirm its safety. Research indicates that combining creatine with resistance training can increase muscle mass and strength in older adults.

Whey protein also has a strong safety record. It effectively improves muscle conditions related to aging, such as muscle loss. Whey protein helps build muscle and improve strength, especially in older individuals.

Overall, both creatine and whey protein are generally well-tolerated and have shown positive effects in those dealing with muscle loss. However, consulting a healthcare provider before starting any new supplement routine is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for sarcopenia because they combine creatine and whey protein with resistance-band training to potentially enhance muscle strength and mass more effectively. Unlike standard treatments that often focus solely on resistance exercise or protein supplementation individually, this approach leverages the synergistic effects of creatine and whey protein together. Creatine is known for boosting energy in muscle cells, while whey protein provides essential amino acids for muscle repair, making this combination a promising strategy to combat muscle loss in older adults.

What evidence suggests that this trial's treatments could be effective for sarcopenia?

This trial will compare the effects of Whey Protein alone and a combination of Creatine and Whey Protein on muscle mass and strength. Research has shown that both creatine and whey protein can increase muscle mass and strength, especially when combined with weight training. Studies have found that taking creatine with exercise significantly improves strength and builds lean muscle. Similarly, whey protein boosts muscle performance and increases muscle mass in older adults experiencing age-related muscle loss. While using creatine and whey protein together does not seem to provide additional benefits beyond what each offers alone, both are effective individually. Overall, these supplements, especially when used with weight training, can help prevent muscle loss and improve physical function. ^{4 6 7 8 9}

Who Is on the Research Team?

Darren Candow

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9998208/

The Effects of Protein and Supplements on Sarcopenia in ... Many studies regularly showed that creatine supplementation increases strength, lean mass, and muscle morphology with heavy resistance exercise more so than ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022316625000240

Comparison of the Effectiveness of Protein ... The combined intervention also showed significant improvements in muscle mass (SMD: 1.49; 95% CI: 0.11, 2.67). The combined intervention (SMD: 2.74; 95% CI: ...

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2019.00124/full

Variables Influencing the Effectiveness of Creatine ... Results across individual studies suggest that the combination of creatine and protein does not provide additional muscle benefits compared to creatine or ...

4. bpspubs.onlinelibrary.wiley.com bpspubs.onlinelibrary.wiley.com/doi/10.1002/prp2.70019

Nutritional strategies for improving sarcopenia outcomes in ... Therefore, creatine supplementation may be an effective tool, when associated with resistance training, to improve gains in muscle mass, muscle ...

5. mdpi.com mdpi.com/2072-6643/16/7/941

Comparative Efficacy of Different Protein Supplements on ... Our findings suggest whey protein yields the optimal supplements to counter sarcopenia in older individuals undergoing RT.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S8756328222001442

Focus on sarcopenia, osteoporosis, frailty and Cachexia The combination of creatine supplementation and resistance training increases lean mass and muscle strength in aging adults.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10591413/

Benefits and side effects of protein supplementation ... Whey protein supplementation has been shown to be effective in improving sarcopenic conditions and weight status in SO individuals.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07029243

Prehab and Creatine/Whey Supplementation in Frailty ... This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining ...

9. mdpi.com mdpi.com/2218-273X/9/11/642

Muscular Atrophy and Sarcopenia in the Elderly: Is There a ... Numerous well-controlled studies involving different populations have shown that creatine is a safe dietary supplement Nonetheless, data in older adults are ...