NCT01418469

Brief Summary

Studies on resting human muscle show that ingestion of the branched-chain amino acids (BCAA): leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism. However, the effects of BCAA intake on protein metabolism during exercise are less clear. When BCAA were supplied as single amino acids, without other amino acids and/or carbohydrates, no effects were observed on protein kinetics. On the other hand, ingestion of BCAA during running appeared to reduce the catabolic effect of running on muscle protein metabolism. These experiments were all performed with mixtures of the BCAA with or without carbohydrates but not in the form of complete meals with food protein as a basis. Therefore, it is still unknown whether a protein meal, containing a substantial amount of BCAA is beneficial during exercise by inducing an anabolic effect. Whey and Casein protein contain a substantial amount of BCAA in contrast to Soy protein. Therefore, it is hypothesized that milk-based proteins are a better and more physiological source of BCAA during exercise and will lead to more protein anabolism. Most of the available studies have been carried out in young and fit humans but there are hardly any data are available in the increasing population of the elderly. Therefore it is still unknown whether a BCAA rich protein meal can enhance the anabolic effect of exercise in older individuals. Besides sarcopenia, a substantial part of the elderly is suffering from a chronic systemic disease such as chronic obstructive pulmonary disease (COPD). COPD represents an important health care problem. COPD is the fourth leading cause of death and will be the third leading cause worldwide in 2020. Besides the local impairment, COPD is a chronic wasting disease, associated with alterations in intermediary metabolism. Substantial disturbances have been found in BCAA (and related) metabolism in these patients at rest and during exercise. It might therefore be of clinical relevance to study the metabolic effects of BCAA rich protein meals in patients with COPD at rest and during exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Dec 2002

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

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

December 1, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
Last Updated

August 17, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

August 9, 2011

Last Update Submit

August 16, 2011

Conditions

Keywords

COPDprotein metabolismbranched-chain amino acid metabolismexerciseprotein feeding

Outcome Measures

Primary Outcomes (1)

  • Change in Net whole body protein synthesis

    Net whole body protein synthesis during protein feeding and the response to a 20 min cycle exercise bout

    6 hours

Secondary Outcomes (9)

  • Change in whole body protein synthesis rate

    6 hours

  • Change in Leucine turnover

    6 hours

  • Change in Isoleucine turnover

    6 hours

  • Change in Valine turnover

    6 hours

  • Change in plasma lactate concentration

    6 hours

  • +4 more secondary outcomes

Study Arms (4)

Caseinate protein intake

EXPERIMENTAL

18 mg protein/kg body weight caseinate and 46 mg maltodextrin / kg body weight per 20 min sip feeding

Dietary Supplement: Caseinate

Whey protein isolate intake

EXPERIMENTAL

18 mg protein/kg body weight whey protein isolate and 46 mg maltodextrin / kg body weight per 20 min sip feeding

Dietary Supplement: Whey protein isolate

Soy protein intake

EXPERIMENTAL

18 mg protein/kg body weight soy and 46 mg maltodextrin / kg body weight per 20 min sip feeding

Dietary Supplement: Soy

soy+BCAA protein intake

EXPERIMENTAL

18 mg protein/kg body weight soy+BCAA and 46 mg maltodextrin / kg body weight per 20 min sip feeding

Dietary Supplement: soy+BCAA

Interventions

CaseinateDIETARY_SUPPLEMENT

18 mg protein/kg body weight caseinate and 46 mg maltodextrin / kg body weight per 20 min sip feeding

Also known as: casein
Caseinate protein intake
Whey protein isolateDIETARY_SUPPLEMENT

18 mg protein/kg body weight whey protein isolate and 46 mg maltodextrin / kg body weight per 20 min sip feeding

Also known as: Whey
Whey protein isolate intake
SoyDIETARY_SUPPLEMENT

18 mg protein/kg body weight soy and 46 mg maltodextrin / kg body weight per 20 min sip feeding

Soy protein intake
soy+BCAADIETARY_SUPPLEMENT

18 mg protein/kg body weight soy+BCAA and 46 mg maltodextrin / kg body weight per 20 min sip feeding

soy+BCAA protein intake

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Irreversible chronic airflow limitation (FEV1 \<70% of predicted)
  • Clinically stable condition

You may not qualify if:

  • Oxygen supplementation
  • Respiratory tract infection or exacerbation of his disease at least 4 weeks prior to the study
  • Oral corticosteroids as maintenance medication
  • Other concomitant metabolic disease (ie malignancy, cardiac failure, recent surgery, severe endocrine, hepatic or renal disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC

Maastricht, Netherlands

Location

Related Publications (4)

  • Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Supplementation of soy protein with branched-chain amino acids alters protein metabolism in healthy elderly and even more in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2007 Feb;85(2):431-9. doi: 10.1093/ajcn/85.2.431.

  • Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Altered interorgan response to feeding in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2005 Aug;82(2):366-72. doi: 10.1093/ajcn.82.2.366.

  • Engelen MP, De Castro CL, Rutten EP, Wouters EF, Schols AM, Deutz NE. Enhanced anabolic response to milk protein sip feeding in elderly subjects with COPD is associated with a reduced splanchnic extraction of multiple amino acids. Clin Nutr. 2012 Oct;31(5):616-24. doi: 10.1016/j.clnu.2012.04.006. Epub 2012 Jun 6.

  • Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Casein protein results in higher prandial and exercise induced whole body protein anabolism than whey protein in chronic obstructive pulmonary disease. Metabolism. 2012 Sep;61(9):1289-300. doi: 10.1016/j.metabol.2012.03.001. Epub 2012 Apr 17.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

CaseinsWhey

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPhosphoproteinsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Nicolaas EP Deutz, MD, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 17, 2011

Study Start

December 1, 2002

Primary Completion

December 1, 2003

Study Completion

December 1, 2004

Last Updated

August 17, 2011

Record last verified: 2011-08

Locations