Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|
|
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
- Improved quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
|
| Placebo Comparator: 2 |
Dietary Supplement: Probiotic Yogurt D: Placebo -- no added micronutrients
175g/day probiotic yogurt
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Clinically tested CD4 lymphocyte count between 200-400cells/mL (HIV population)
- Confirmed cancer by physician (cancer population)
- Confirmed HIV by physician (HIV population)
Exclusion Criteria:
- Opportunistic infection
- Mental illness impairing ability to comply with study
- Pregnancy
- Currently consuming micronutrient supplement or probiotic
- Clinical history of lactose-intolerance or cow's milk allergies
- Require surgery, radiation or chemotherapy during the study
Contacts and Locations| Canada, Ontario | |
| St. Joseph's Hospital | |
| London, Ontario, Canada, N6A 4V2 | |
| Principal Investigator: | Gregor Reid, PhD | Lawson Health Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Dr. Gregor Reid, University of Western Ontario |
| ClinicalTrials.gov Identifier: | NCT00517803 History of Changes |
| Other Study ID Numbers: | R-07-220, 13468 |
| Study First Received: | August 16, 2007 |
| Last Updated: | July 6, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Lawson Health Research Institute:
|
micronutrients immunodeficiency probiotics yogurt |
Healthy Acquired Immunodeficiency Syndrome Complementary Therapies |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Neoplasms, Second Primary Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Neoplasms Micronutrients Trace Elements Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on February 26, 2013
