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Sponsored by: |
Lawson Health Research Institute |
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Information provided by: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00517803 |
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].
Condition | Intervention |
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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 Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies: A Randomized, Placebo-Controlled Trial |
Estimated Enrollment: | 30 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
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1: Experimental |
Dietary Supplement: Probiotic Yogurt B: with various micronutrients
175g probiotic yogurt / day 25% RDA for each nutrient
Dietary Supplement: Probiotic Yogurt A: Kaiser micronutrients
175g probiotic yogurt/ day 25% RDA for each nutrient
Dietary Supplement: Probiotic yogurt C: with basic micronutrients
175g yogurt/ day 25% RDA for each nutrient
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2: Placebo Comparator |
Dietary Supplement: Probiotic Yogurt D: Placebo -- no added micronutrients
175g/day probiotic yogurt
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gregor Reid, PhD | 519-661-2111 ext 65256 | gregor@uwo.ca |
Contact: Jaimie Hemsworth, HBSc | 519-661-2111 ext 28035 | jhemswor@uwo.ca |
Canada, Ontario | |
St. Joseph's Hospital | Recruiting |
London, Ontario, Canada, N6A 4V2 | |
Sub-Investigator: Jaimie C Hemsworth, HBSc |
Principal Investigator: | Gregor Reid, PhD | Lawson Health Research Institute |
Study ID Numbers: | R-07-220, 13468 |
Study First Received: | August 16, 2007 |
Last Updated: | September 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00517803 |
Health Authority: | Canada: Health Canada |
micronutrients immunodeficiency probiotics yogurt |
Healthy Acquired Immunodeficiency Syndrome Complementary Therapies |
Virus Diseases Sexually Transmitted Diseases, Viral Neoplasms, Second Primary HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
Neoplasms RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |