Effect Study of Marine Protein Hydrolysates to Prevent Loss of Muscle Mass and Physical Function in Frail Elderly

NCT02890290 | Completed

• 1 other identifier: Nygard8362
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether a marine protein hydrolysate given as a supplement can prevent age related loss of muscle mass and loss of physical function in frail elderly. The study will recruit elderly living at home with help from municipal health care services, and a secondary goal of the study is to describe food habits, seafood intake and nutritional status in this group of patients. Edit: the recruitment procedure was changed in august 2017, to include elderly without help from municipal health care services. Participants are now recruited trough media and organizations for elderly, and these changes in recruitment procedure was approved by the ethics committee august 2017.

Conditions

Sarcopenia

Keywords

Frail Elderly; Diet, Food, and Nutrition; physical function; marine protein hydrolysates; protein intake; seafood intake; ageing; old; nutrition; frail

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB)

  physical test assessing balance, lower limb function and gait speed.

  6 and 12 months

Secondary Outcomes (4)

• Grip strength

  6 and 12 months

• Gait speed

  6 and 12 months

• Health related quality of life

  6 and 12 months

• Antropometric measures

  6 and 12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Marine protein hydrolysate pills (3000mg)

Dietary Supplement: Marine Protein hydrolysate

Control

PLACEBO COMPARATOR

Placebo pills (gum arabicum)

Dietary Supplement: Placebo

Interventions

Marine Protein hydrolysate DIETARY_SUPPLEMENT

The participants will take the supplement in form of tablets and will be instructed to take five tablets twice a day, preferably in relation to meals, however, not the dinner meal. Each tablet contains 300 mg of marine protein hydrolysates (Nx6.25). The tablets are produced by Flexipharma AS.

Intervention

Placebo DIETARY_SUPPLEMENT

Placebo tablets will be made based on gum arabicum. The tablets are produced by Flexipharma AS.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• able and willing to give consent
• Must be able to swallow tablets

You may not qualify if:

• diabetes (recieve treatment)
• active cancer illness
• progressive muscle illness (e.g. multiple sclerosis ALS)
• kidney failure
• short life expectancy (\<1år)
• allergies of fish protein.

Sponsors & Collaborators

• Molde University College: lead

Related Publications (5)

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

• Freiberger E, de Vreede P, Schoene D, Rydwik E, Mueller V, Frandin K, Hopman-Rock M. Performance-based physical function in older community-dwelling persons: a systematic review of instruments. Age Ageing. 2012 Nov;41(6):712-21. doi: 10.1093/ageing/afs099. Epub 2012 Aug 10.

  PMID: 22885845 BACKGROUND

• Dodds RM, Syddall HE, Cooper R, Benzeval M, Deary IJ, Dennison EM, Der G, Gale CR, Inskip HM, Jagger C, Kirkwood TB, Lawlor DA, Robinson SM, Starr JM, Steptoe A, Tilling K, Kuh D, Cooper C, Sayer AA. Grip strength across the life course: normative data from twelve British studies. PLoS One. 2014 Dec 4;9(12):e113637. doi: 10.1371/journal.pone.0113637. eCollection 2014.

  PMID: 25474696 BACKGROUND

• Kwon S, Perera S, Pahor M, Katula JA, King AC, Groessl EJ, Studenski SA. What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study). J Nutr Health Aging. 2009 Jun;13(6):538-44. doi: 10.1007/s12603-009-0104-z.

  PMID: 19536422 BACKGROUND

• Nygard LAK, Mundal I, Dahl L, Saltyte Benth J, Rokstad AMM. Nutrition and physical performance in older people-effects of marine protein hydrolysates to prevent decline in physical performance: a randomised controlled trial protocol. BMJ Open. 2018 Oct 8;8(10):e023845. doi: 10.1136/bmjopen-2018-023845.

  PMID: 30297351 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share