None listed
Conditions
Brief summary
Folic acid is a form of the B-viitamin folate which is added to the food supply in several countries to prevent birth defects. While birth defects have declined in these countries there are some health concerns with exposing the entire population to folic acid for a lifetime. Other forms of folate such as reduced folates may be safer than folic acid. However, in their present form they are not as stable as folic acid and cannot be added to food. We have developed a process of protecting (microencapsulating) reduced folates so they are more stable. We need to show that these folate can be absorbed. We propose to conduct load tests in 16 people to determine if microencapsulated folates increase blood folate levels to the same extent as non microencapsulated folate.
Interventions
This randomised crossover study will be conducted in sixteen healthy adults. Participants will attend 8 morning clinics approximately 1 week apart. Participants will be assigned to one of 8 treatments each week using a balanced design; 1) placebo (methyl cellulose), 2) 0.4 mg non-microencapsulated folic acid, 3) 0.4 mg non-microencapsulated L-5-methyltetrahydrofolate (L-MTHF) 4) 0.4 mg microencapsulated folic acid with 75% stearate coating, 5) 0.4 mg microencapsulated L-MTHF with 75% stearate c
This randomised crossover study will be conducted in sixteen healthy adults. Participants will attend 8 morning clinics approximately 1 week apart. Participants will be assigned to one of 8 treatments each week using a balanced design; 1) placebo (methyl cellulose), 2) 0.4 mg non-microencapsulated folic acid, 3) 0.4 mg non-microencapsulated L-5-methyltetrahydrofolate (L-MTHF) 4) 0.4 mg microencapsulated folic acid with 75% stearate coating, 5) 0.4 mg microencapsulated L-MTHF with 75% stearate coating 6) 0.4 mg microencpaulsated folic acid with 25% stearate coating 7) 0.4 mg microencapsulated folic acid with 75% stearate coating in milk powder, 8) 0.4 mg microencapsulated L-MTHF with 75% stearate coating in milk powder. Treatments 1 through 6 will be given in capsule form and treatments 7 and 8 will be given in milk powder. At each visit, a venous catheter will be inserted and a baseline blood sample drawn. The participants will then be instructed to consume a capsule or milk containing the folate or placebo. Blood samples (5 ml) will be drawn every 1/4 hour for the first two hours and then every 1/2 hour for the next 2 hours and then every hour for an additional four hours. A standardized low folate breakfast and lunch will be offered between baseline and ½ hour blood collections and between the 4 and 5 hour blood collections, respectively.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
- Males and Females aged 18-65 years
Exclusion criteria
Vitamin supplement users - People with a chronic disease e.g. heart disease, diabetes - People with allergies to milk -Men and women with anemia at baseline. (Haemoglobin (Hb) <120 /L females <140 g/L males) -People taking drugs know to interefere with folate metabolism (i.e. methotextrate, sulphasalazine, phenytoin, and others)
Outcome results
None listed