## Protocol Section
### Identification Module
**NCT ID:** NCT01074879

**Acronym:** IceProQualita

**Brief Title:** Protein Ingestion and Resistance Exercise in Elderly

**Official Title:** Effects of Protein Quantity and Quality in Combination With Resistance Exercise on Muscle Mass and -Strength in Icelandic Elderly.

#### Organization Study ID Info
**ID:** 071323007
#### Organization
**Class:** OTHER
**Full Name:** University of Iceland
### Status Module
#### Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-02-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-02-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Start Date
**Date:** 2008-08

**Status Verified Date:** 2010-02

#### Study First Post Date
**Date:** 2010-02-24
**Type:** ESTIMATED
**Study First Submit Date:** 2010-02-23
**Study First Submit QC Date:** 2010-02-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Landspitali University Hospital Research Fund

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Iceland

#### Responsible Party

**Old Name Title:** Prof. Inga Thorsdottir

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Elderly

- protein consumption

- resistance exercise

- muscle mass

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 220

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 20 g whey protein + 20 g carbohydrates

**Intervention Names:**

- Dietary Supplement: Whey protein

**Label:** Whey protein

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 20 g milk protein + 20 g carbohydrates

**Intervention Names:**

- Dietary Supplement: Milk protein

**Label:** Milk protein

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 40 g carbohydrates

**Intervention Names:**

- Dietary Supplement: Carbohydrates

**Label:** Carbohydrates

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Whey protein

**Description:** Dietary supplement after training

**Name:** Whey protein

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Milk protein

**Description:** Dietary supplement after training

**Name:** Milk protein

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- Carbohydrates

**Description:** Dietary supplement after training

**Name:** Carbohydrates

**Type:** DIETARY_SUPPLEMENT

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 65 years and older

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Reykjavik

**Country:** Iceland

**Facility:** Unit for Nutrition Research

**Zip:** 101

### References Module

#### References

**Citation:** 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:** 32859321

**Citation:** 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:** 30906596

**Citation:** 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:** 28890833

**Citation:** 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:** 26412290

**Citation:** 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:** 26193865

**Citation:** 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:** 25431460

**Citation:** 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:** 24293371

**Citation:** 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:** 23890349

**Citation:** 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:** 23486511

**Citation:** 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:** 23317926

**Citation:** 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:** 22496538

**Citation:** 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:** 22238003

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000002614

- Term: Chelating Agents

- ID: D000064449

- Term: Sequestering Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M5616

- Name: Caseins

- Relevance: HIGH

- As Found: Subacute

- ID: M5860

- Name: Chelating Agents

- Relevance: LOW

- As Found: Unknown

- ID: T435

- Name: Whey Protein

- Relevance: HIGH

- As Found: Ingredients

### Intervention Browse Module - Meshes

- ID: D000002364

- Term: Caseins

### Misc Info Module

- Version Holder: 2024-05-24
