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Trial registered on ANZCTR


Registration number
ACTRN12614000159651
Ethics application status
Approved
Date submitted
30/01/2014
Date registered
10/02/2014
Date last updated
10/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Whey protein isolate as a source of vitamin B12 and to lower homocysteine and methylmalonic acid in older person
Scientific title
A randomised controlled trial evaluating whey protein as a source of vitamin B12 and its effects on serum B12, holotranscobalamin (HTC) and methylmalonic acid levels in the older person
Secondary ID [1] 284010 0
Nil known
Universal Trial Number (UTN)
U1111-1152-7783
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aging older healthy people 291043 0
Sub-clinical serum levels of vitamin B12 in older people 291065 0
Condition category
Condition code
Public Health 291383 291383 0 0
Health promotion/education
Diet and Nutrition 291409 291409 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cross-over design. Whey protein isolate provided by Myopure will be used for the intervention arm to see if it increases vitamin B12 levels in older people with sub-clinical serum levels of vitamin B12. The trial duration is 8 weeks. Mode of administration for this trial is oral. After that there is sixteen week wash period and then the second arm of the trial will be performed using soy protein isolate for another 8 weeks. Both these products will be taken along with the diet (50 gm daily; 25 gm at a time; to be taken twice daily - once with the breakfast and once with dinner). During the wash out period, when participants are on normal diet, their vitamin B12 levels will be monitored. If it is more than 300 pmol/L, then their B12 will be brought to the study limits by restricting/modifying their diet.

Participants will be given the chart so that they can mark on the chart to show the compliance adherence. They will return this chart at the end of every intervention so that w e can monitor the degree of adherence. Participants will be required to attend the clinic at mid point of the sixteen week wash period. They will provid the blood sample and if B12 levels are increased, then the dietician will suggest the food items to be avoided during the next 3-4 week period. Once the B12 level returns to the levels required in the intervention, they will participate in the trial.
Intervention code [1] 288695 0
Lifestyle
Comparator / control treatment
As mentioned above, the study involves two parts: one with whey protein isolate and other with soy protein isolate. Soy protein isolate is being used as a control treatment option.
Control group
Active

Outcomes
Primary outcome [1] 291377 0
Change in serum B12

HPLC based assay will be used for measuring the serum
B12 levels.
Timepoint [1] 291377 0
0, 8, 16, 24 and 32 weeks
Primary outcome [2] 291378 0
Change in serum holotranscobalamin levels

ELISA based assay will be used to measure serum holotranscobalamin levels .
Timepoint [2] 291378 0
0, 8, 16, 24 and 32 weeks
Primary outcome [3] 291379 0
Change in serum Methylmalonic acid

Capillary-gas chromatography based assay will be used to measure this metabolite
Timepoint [3] 291379 0
0, 8, 16, 24 and 32 weeks
Secondary outcome [1] 306626 0
Change in serum homocysteine levels

Mass spectroscopy based assay will be used for this measurement.
Timepoint [1] 306626 0
0, 8, 16, 24 and 32 weeks
Secondary outcome [2] 306627 0
Change in serum folate levels

HPLC based assay will be used.
Timepoint [2] 306627 0
0, 8, 16, 24 and 32 weeks
Secondary outcome [3] 306628 0
Change in plasma brain-derived neurotrophic factor (BDNF)

Plasma levels of BDNF will be measured using enzyme immunoassay
Timepoint [3] 306628 0
0. 8, 16, 24 and 32 weeks
Secondary outcome [4] 306629 0
Chromosomal damage biomarkers

Tissue culture technique will be used to grow the lymphocytes. After 44 hours of the culture set up, cytokinesis is blocked by adding cytochalasin. Cytokinesis block micronucleus assay is the main assay that will be performed to assess the chromosomal damage biomarkers that include micronucleus formation, nuclear buds, nucleoplasmic bridges, apoptosis and necrosis.
Timepoint [4] 306629 0
0, 8, 16, 24 and 32 weeks
Secondary outcome [5] 306630 0
Change in telomere length as assessed by the Real-Time based qPCR assay
Timepoint [5] 306630 0
0, 8, 16, 24 and 32 weeks
Secondary outcome [6] 306631 0
mitochondrial DNA damage biomarkers assessed by real-time based qPCR assay
Timepoint [6] 306631 0
0, 8, 16, 24 and 32 weeks
Secondary outcome [7] 306632 0
Cognitive function tests

It includes word list immediate recall, word list delayed recall, Digit Symbol Coding, Verbal Fluency, 2-choice reaction time, Odd-man-out reaction time, Operation Span,
Number Memory Scanning, Colour Stroop. The battery includes some speed tasks, which are
more likely to be sensitive to subtle changes. It also encompasses a number of different cognitive
domains that could change due to intervention.
Timepoint [7] 306632 0
0, 8, 16, 24 and 32 weeks

Eligibility
Key inclusion criteria
Healthy subjects

Not undergoing treatment for any life-threatening diseases

Not taking vitamin B12/choline/antioxidants at doses that exceed 25% of the Recommended Dietary Allowance (RDA)

Should have serum concentration of B12 between 100 to 300pmol/L, plasma MethylMalonicAcid >0.26umol/L and serum creatinine concentration of 120umol/L or less

Able to consume required quantities of either Whey protein isolate or Soy protein isolate
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to attend an information session and/or read the information sheet

Current smokers

Those who drink more than two standard drinks of alcohol per day

Body mass index (BMI) 30 or greater

Diagnosed with diabetes

Lactose intolerance

History of pernicious anaemia or atrophic gastritis

Regular use of antacids

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Bio-availability
Statistical methods / analysis
Our previous study in older men (aged 50-70y) showed that they had a mean serum vitamin B12 of 283 pmol/l with a standard deviation of 108 pmol/l. With 50 subjects per group the intervention will have 90% power to detect an increase of 50pmol/L at P<0.05 which is an effect size of 18%. For comparison, another intervention study published by of Eussen and co-workers showed that supplementation with 2.5ug/d of vitamin B12 orally for 16 weeks produced a 20% increase in serum B12 in elderly subjects aged 70y or greater (mean 80y). If, in a worst case scenario, 20%
of participants drop out of the study, it will still be possible to detect an effect size of 18% at 80% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288633 0
Commercial sector/Industry
Name [1] 288633 0
Dairy Research Institute, United States of America
Country [1] 288633 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Dairy Research Institute, United States of America
Address
10255 West Higgins Road Suite 900
Rosemont, IL 60018-5616
Country
United States of America
Secondary sponsor category [1] 287340 0
Government body
Name [1] 287340 0
Commonwealth Scientific and Industrial Research Organisation
Division of Animal, Food and Health Sciences
Address [1] 287340 0
gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000
South Australia
Country [1] 287340 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45926 0
Prof Michael Fenech
Address 45926 0
Commonwealth Scientific and Industrial Research Organistion
Division of Animal, Food and Health Sciences
gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000
South Australia
Country 45926 0
Australia
Phone 45926 0
+61 8 83038880
Fax 45926 0
Email 45926 0
michael.fenech@csiro.au
Contact person for public queries
Name 45927 0
Anne McGuffin
Address 45927 0
Commonwealth Scientific and Industrial Research Organistion
Division of Animal, Food and Health Sciences
gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000
South Australia
Country 45927 0
Australia
Phone 45927 0
+61 8 8303 8988
Fax 45927 0
Email 45927 0
anne.mcguffin@csiro.au
Contact person for scientific queries
Name 45928 0
Varinderpal Dhillon
Address 45928 0
Commonwealth Scientific and Industrial Research Organistion
Division of Animal, Food and Health Sciences
gate 13, Kintore Avenue
PO BOX 10041
Adelaide 5000
South Australia
Country 45928 0
Australia
Phone 45928 0
+61 8 83038932
Fax 45928 0
Email 45928 0
varinderpal.dhillon@csiro.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.