None listed
Conditions
Brief summary
Vitamin B12 is essential for cells in the body to function and regenerate themselves properly. Deficiency in this vitamin causes damage to the genetic material (DNA), anaemia, nervous system malfunction, loss of mental capacity and dementia. Older persons have a reduced ability to absorb and utilise vitamin B12 efficiently and are therefore at greater risk of vitamin B12 deficiency. Cow’s milk is an important source of vitamin B12. The whey fraction of milk contains highest amount of vitamin B12. This study will test whether consumption of whey protein isolated from cow’s milk: increases vitamin B12 levels in blood, reduces DNA damage and improves memory and other mental functions. If this hypothesis is proven, whey protein isolate could be recommended as a part of a dietary pattern designed to increase vitamin B12 levels in older persons.
Interventions
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
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.
Sponsors
Dairy Research Institute, United States of America
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed