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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03111979
Other study ID # 343
Secondary ID
Status Suspended
Phase Phase 4
First received April 7, 2017
Last updated April 12, 2017
Start date April 2014
Est. completion date October 2018

Study information

Verified date April 2017
Source Nottingham Trent University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The older population is the fastest growing age group worldwide, but it is also the most susceptible to chronic diseases and disabilities. One of the most common negative consequences of aging is the decline in muscle mass, strength and power. This is most notable in lower limb muscles. These muscles are required for the performance of daily activities including walking, stair climbing and standing up from sitting. Regular exercise is considered one of the most effective measures to slow, and even reverse the progression of muscle weakness. Nevertheless older adults may notice a decline in their capability to undertake regular exercises, this may be due to a decline in their muscle's ability to buffer pH. Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the extension of physical performance, counteracting the decline the muscle's ability to buffer pH. Yet this pH buffering process it largely restricted by the amount of β-alanine available in the human body. β-alanine is already known to decline in older individuals due to a reduction in food products (meat, fish and poultry). Yet through either consumption of β-alanine rich food, or through short-term supplementation, β-alanine is raised, increasing carnosine concentrations. Improved β-alanine levels can potentially advance exercise performance, for example significant improvements in time to exhaustion on both a constant (37%) and incremental (12%) treadmill tests have been demonstrated. It is therefore proposed that via β-alanine supplementation, an individual's perception of their frailty, maintenance of health and independent living can be improved in older individuals.

However, these findings are based on participants, both young and older, who are well-rested with no prior exercise or fatigue to the assessed muscles. It remains unclear if β-alanine supplementation will aid in the buffering of pH when the muscle has already been fatigued. Therefore this investigation hopes to examine the effects of 4 week β-alanine supplementation on lower limb contractile and force properties, pre and post muscle specific fatigue.


Recruitment information / eligibility

Status Suspended
Enrollment 24
Est. completion date October 2018
Est. primary completion date April 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

- All participants will be defined as 'medically stable' for exercise studies, as proposed by Grieg et al. (1994). This criteria was designed both for safety and to define degrees of freedom from diseases which might alter exercise performance (Greig et al., 1994).

Exclusion Criteria:

- Participants will be excluded if they are vegetarian/vegan or have been using ß-alanine or creatine supplements within the past 6 months. They will also be excluded if they have participated in a resistance training programme in the last 6 months. These criteria will apply throughout the whole study, with any participants immediately excluded from the study if any of these medical conditions should arise.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
beta-alanine

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nottingham Trent University

References & Publications (4)

Artioli GG, Gualano B, Smith A, Stout J, Lancha AH Jr. Role of beta-alanine supplementation on muscle carnosine and exercise performance. Med Sci Sports Exerc. 2010 Jun;42(6):1162-73. doi: 10.1249/MSS.0b013e3181c74e38. Review. — View Citation

Harris RC, Sale C. Beta-alanine supplementation in high-intensity exercise. Med Sport Sci. 2012;59:1-17. doi: 10.1159/000342372. Epub 2012 Oct 15. Review. — View Citation

Sale C, Artioli GG, Gualano B, Saunders B, Hobson RM, Harris RC. Carnosine: from exercise performance to health. Amino Acids. 2013 Jun;44(6):1477-91. doi: 10.1007/s00726-013-1476-2. Epub 2013 Mar 12. Review. — View Citation

Sale C, Saunders B, Harris RC. Effect of beta-alanine supplementation on muscle carnosine concentrations and exercise performance. Amino Acids. 2010 Jul;39(2):321-33. doi: 10.1007/s00726-009-0443-4. Epub 2009 Dec 20. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Half relaxation time The time taken to decline to 50% maximum following a evoked twitch contraction 4 weeks
Secondary Force frequency relationship Assessed during electrically evoked contractions 4 weeks
Secondary Time to peak tension The time taken to reach peak in evoked twitch contractions 4 weeks
Secondary Electromechanical delay The time between EMG onset and force onset in twitch contractions 4 weeks
Secondary Maximal voluntary force production The maximal force produced during a voluntary isometric contraction 4 weeks
Secondary Explosive voluntary force production The quickest rate of force developed during voluntary isometric contractions at greater than 80% of voluntary maximum, with no pre-tension or swinging back of the assessed leg. 4 weeks
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