Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies

Summary

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 \[Kaiser, et.al 2006\].

Conditions

• HIV Infections
• Cancer, Second Primary

Interventions

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

DIETARY_SUPPLEMENT

Probiotic Yogurt D: Placebo -- no added micronutrients

175g/day probiotic yogurt

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  lead OTHER

Principal Investigators

• Gregor Reid, PhD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-09-07

Primary Completion

2009-03-02

Completion

2009-03-02

Countries

• Canada

Study Locations