Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
We hypothesize that micronutrient fortified probiotic yogurt can improve nutritional status and enhance immunity parameters in subjects HIV/AIDS and other immunodeficiencies.
We have developed a micronutrient-fortified probiotic yogurt that has safe and beneficial levels of micronutrients for human consumption. This has been undertaken with the guidance of Edward Farnworth, a senior research scientist at Agri-Food Canada-Food Research and Development Centre, St. Hyacinthe, Quebec
We will now measure nutritional parameters (height, weight, serum albumin, serum nutrient levels, blood urea, liver function tests (AST, ALT)) to determine if there is a statistically significant difference between the various levels of fortified probiotic yogurt and the placebo on the nutritional parameters of the subjects consuming the yogurt.
We will measure immunological parameters (CD4 lymphocyte count, CBC, levels of TNFα, IL-12, IL-10, and G-CSF [Kim, et.al. 2006]) in order to determine if there is a statistically significant difference using fortified probiotic yogurt compared to a placebo.
In addition, we will determine if the micronutrient-fortified probiotic yogurt has a significant impact on the overall quality of life for the subjects using the "linear analogue self assessment" tool [Kaiser, et.al 2006].
|HIV Infections Cancer, Second Primary||Dietary Supplement: Probiotic Yogurt B: with various micronutrients Dietary Supplement: Probiotic Yogurt A: Kaiser micronutrients Dietary Supplement: Probiotic yogurt C: with basic micronutrients Dietary Supplement: Probiotic Yogurt D: Placebo -- no added micronutrients|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies: A Randomized, Placebo-controlled Trial|
- Statistically significant improvement of immune status (CD4) Statistically significant improvement of nutritional status [ Time Frame: Baseline and Follow-up for each yogurt type ]
- Improved quality of life [ Time Frame: 4 months ]
|Actual Study Start Date:||September 7, 2007|
|Study Completion Date:||March 2, 2009|
|Primary Completion Date:||March 2, 2009 (Final data collection date for primary outcome measure)|
Dietary Supplement: Probiotic Yogurt B: with various micronutrients
175g probiotic yogurt / day 25% RDA for each nutrientDietary Supplement: Probiotic Yogurt A: Kaiser micronutrients
175g probiotic yogurt/ day 25% RDA for each nutrientDietary Supplement: Probiotic yogurt C: with basic micronutrients
175g yogurt/ day 25% RDA for each nutrient
|Placebo Comparator: 2||
Dietary Supplement: Probiotic Yogurt D: Placebo -- no added micronutrients
175g/day probiotic yogurt
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00517803
|St. Joseph's Hospital|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator:||Gregor Reid, PhD||Lawson Health Research Institute|