NCT01074879

Brief Summary

The mail goal of this randomized controlled, dietary intervention study is to investigate whether protein supplementation in combination with resistance exercise can increase muscle mass and strength in elderly. Loss of muscle mass and -strength is frequent in this group. Participants (N = 220, equal distribution between men and women) are randomized to one of three groups receiving different quantities and qualities of protein supplementation after exercise. The results of this study will be used to form recommendations regarding diet and exercise for the prevention of this frequent health problem in elderly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

1.3 years

First QC Date

February 23, 2010

Last Update Submit

February 23, 2010

Conditions

Healthy

Keywords

Elderlyprotein consumptionresistance exercisemuscle mass

Study Arms (3)

Whey protein

EXPERIMENTAL

20 g whey protein + 20 g carbohydrates

Dietary Supplement: Whey protein

Milk protein

EXPERIMENTAL

20 g milk protein + 20 g carbohydrates

Dietary Supplement: Milk protein

Carbohydrates

ACTIVE COMPARATOR

40 g carbohydrates

Dietary Supplement: Carbohydrates

Interventions

Whey proteinDIETARY_SUPPLEMENT

Dietary supplement after training

Whey protein
Milk proteinDIETARY_SUPPLEMENT

Dietary supplement after training

Milk protein
CarbohydratesDIETARY_SUPPLEMENT

Dietary supplement after training

Carbohydrates

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years and older

You may not qualify if:

  • uncontrolled coronary heart disease
  • pharmacological interventions with drugs known to affect muscle mass
  • major orthopedic disease
  • low cognitive function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit for Nutrition Research

Reykjavik, 101, Iceland

Location

Related Publications (12)

  • Og G, M C, Pv J, I T, A R. Associations of physical activity with vitamin D status depends on obesity status in old adults. Clin Nutr ESPEN. 2020 Oct;39:222-226. doi: 10.1016/j.clnesp.2020.06.009. Epub 2020 Jul 12.

    PMID: 32859321DERIVED

  • Geirsdottir OG, Chang M, Jonsson PV, Thorsdottir I, Ramel A. Obesity, Physical Function, and Training Success in Community-Dwelling Nonsarcopenic Old Adults. J Aging Res. 2019 Feb 18;2019:5340328. doi: 10.1155/2019/5340328. eCollection 2019.

    PMID: 30906596DERIVED

  • Geirsdottir OG, Chang M, Briem K, Jonsson PV, Thorsdottir I, Ramel A. Gender, Success, and Drop-Out during a Resistance Exercise Program in Community Dwelling Old Adults. J Aging Res. 2017;2017:5841083. doi: 10.1155/2017/5841083. Epub 2017 Aug 14.

    PMID: 28890833DERIVED

  • Arnarson A, Gudny Geirsdottir O, Ramel A, Jonsson PV, Thorsdottir I. Insulin-Like Growth Factor-1 and Resistance Exercise in Community Dwelling Old Adults. J Nutr Health Aging. 2015 Oct;19(8):856-60. doi: 10.1007/s12603-015-0547-3.

    PMID: 26412290DERIVED

  • Ramel A, Geirsdottir OG, Jonsson PV, Thorsdottiri I. C-Reactive Protein and Resistance Exercise in Community Dwelling Old Adults. J Nutr Health Aging. 2015 Aug;19(7):792-6. doi: 10.1007/s12603-015-0548-2.

    PMID: 26193865DERIVED

  • Geirsdottir OG, Arnarson A, Ramel A, Briem K, Jonsson PV, Thorsdottir I. Muscular strength and physical function in elderly adults 6-18 months after a 12-week resistance exercise program. Scand J Public Health. 2015 Feb;43(1):76-82. doi: 10.1177/1403494814560842. Epub 2014 Nov 27.

    PMID: 25431460DERIVED

  • Arnarson A, Ramel A, Geirsdottir OG, Jonsson PV, Thorsdottir I. Changes in body composition and use of blood cholesterol lowering drugs predict changes in blood lipids during 12 weeks of resistance exercise training in old adults. Aging Clin Exp Res. 2014 Jun;26(3):287-92. doi: 10.1007/s40520-013-0172-0. Epub 2013 Dec 1.

    PMID: 24293371DERIVED

  • Geirsdottir OG, Arnarson A, Ramel A, Jonsson PV, Thorsdottir I. Dietary protein intake is associated with lean body mass in community-dwelling older adults. Nutr Res. 2013 Aug;33(8):608-12. doi: 10.1016/j.nutres.2013.05.014. Epub 2013 Jun 27.

    PMID: 23890349DERIVED

  • Arnarson A, Gudny Geirsdottir O, Ramel A, Briem K, Jonsson PV, Thorsdottir I. Effects of whey proteins and carbohydrates on the efficacy of resistance training in elderly people: double blind, randomised controlled trial. Eur J Clin Nutr. 2013 Aug;67(8):821-6. doi: 10.1038/ejcn.2013.40. Epub 2013 Mar 13.

    PMID: 23486511DERIVED

  • Ramel A, Arnarson A, Geirsdottir OG, Jonsson PV, Thorsdottir I. Glomerular filtration rate after a 12-wk resistance exercise program with post-exercise protein ingestion in community dwelling elderly. Nutrition. 2013 May;29(5):719-23. doi: 10.1016/j.nut.2012.10.002. Epub 2013 Jan 11.

    PMID: 23317926DERIVED

  • Geirsdottir OG, Arnarson A, Briem K, Ramel A, Jonsson PV, Thorsdottir I. Effect of 12-week resistance exercise program on body composition, muscle strength, physical function, and glucose metabolism in healthy, insulin-resistant, and diabetic elderly Icelanders. J Gerontol A Biol Sci Med Sci. 2012 Nov;67(11):1259-65. doi: 10.1093/gerona/gls096. Epub 2012 Apr 10.

    PMID: 22496538DERIVED

  • Geirsdottir OG, Arnarson A, Briem K, Ramel A, Tomasson K, Jonsson PV, Thorsdottir I. Physical function predicts improvement in quality of life in elderly Icelanders after 12 weeks of resistance exercise. J Nutr Health Aging. 2012 Jan;16(1):62-6. doi: 10.1007/s12603-011-0076-7.

    PMID: 22238003DERIVED

MeSH Terms

Interventions

Whey ProteinsMilk ProteinsCarbohydrates

Intervention Hierarchy (Ancestors)

Animal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 24, 2010

Record last verified: 2010-02

Locations

IC(1)