Healthy Males 65-75 Yrs Old Clinical Trial
Official title:
Use of Indicator Amino Acid Oxidation Technique to Determine Protein Requirement of Elderly Male Subjects 65-75 Yrs Old.
| Verified date | January 2018 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Minimal data are available on protein requirements throughout the lifespan. Currently
available recommendations are based on nitrogen balance data. The limitations of the nitrogen
balance method have been well described. Importantly, nitrogen balanced underestimates
requirements.
The current dietary reference intakes (DRI) requirement for healthy adult males is based on
the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was
reanalyzed statistically by Rand et al. and he concluded that the protein requirement of
healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using
indicator amino acid oxidation (IAAO), our group estimated the protein requirement of young
men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).
Currently there are no studies on protein requirement in the elderly. In a recent nutrition
survey conducted by national health and nutrition examination survey (NHANES), the authors
concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0
g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on
the calculations used for ideal body weight some older adults could be getting higher or
lower than requirement. There is no scientifically derived protein estimate for older adults.
Therefore there is a need to measurer protein requirement in that population.
The goal of this study therefore is to measure the protein requirement of male elderly
subjects between the ages of 65 - 75 years using the IAAO technique.
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 65 Years to 75 Years |
| Eligibility |
- Inclusion Criteria: 1. Healthy elderly males between the ages of 65 to 75 years 2. Willingness to participate in the study 3. Males without a chronic disease or acute illness that could affect protein and AA metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications. 4. Males with hypertension if well controlled by medications Exclusion Criteria: 1. Presence of disease known to affect protein and amino acids (AA) requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications. 2. On medications known to affect protein and amino acid metabolism like e.g. steroids. 3. Significant weight loss during the past month. 4. Individual on weight reducing diets. 5. Inability to tolerate the diet or unwilling to have blood drawn from a venous access for the purposes of the study. 6. Significant coffee consumption of more than 2 cups/day (400 mg of caffeine/day) 7. Significant Alcohol consumption of more than one drink/day ( 1 beer, ½ glass of wine) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children |
Canada,
Rafii M, Chapman K, Elango R, Campbell WW, Ball RO, Pencharz PB, Courtney-Martin G. Dietary Protein Requirement of Men >65 Years Old Determined by the Indicator Amino Acid Oxidation Technique Is Higher than the Current Estimated Average Requirement. J Nutr. 2016 Mar 9. pii: jn225631. [Epub ahead of print] — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Urine (for measurement of 13C phenylalanine enrichment) and breath (for measurement of 13CO2 enrichment) samples will be collected on day 3 of the experiment between the 4th and 5th meal and after the 6th and 7th meal. | 10 months |