Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies - Full Text View

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

MedlinePlus related topics:

AIDS Cancer Dietary Supplements

U.S. FDA Resources

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

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Statistically significant improvement of immune status Statistically significant improvement of nutritional status [ Time Frame: 4 months ]

Secondary Outcome Measures:

Improved quality of life [ Time Frame: 4 months ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
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
2: Placebo Comparator	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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517803

Contacts


Contact: Gregor Reid, PhD	519-661-2111 ext 65256	gregor@uwo.ca

Contact: Jaimie Hemsworth, HBSc	519-661-2111 ext 28035	jhemswor@uwo.ca

Locations


Canada, Ontario
	St. Joseph's Hospital	Recruiting
	London, Ontario, Canada, N6A 4V2
	Sub-Investigator: Jaimie C Hemsworth, HBSc

Sponsors and Collaborators

Lawson Health Research Institute

Investigators


Principal Investigator:	Gregor Reid, PhD	Lawson Health Research Institute

More Information

Canadian Research and Development Centre for Probiotics This link exits the ClinicalTrials.gov site

Publications:

Alan DD, Clemens F, Elbourne D, Fasey N, Fletcher AE, Hardy P, Holder GE, Huppert FA, Knight R, Letley L, Richards M, Truesdale A, Vickers M, Uauy R. A randomised controlled trial investigating the effect of n-3 long-chain polyunsaturated fatty acid supplementation on cognitive and retinal function in cognitively healthy older people: the Older People And n-3 Long-chain polyunsaturated fatty acids (OPAL) study protocol [ISRCTN72331636]. Nutr J. 2006 Aug 31;5:20.

Anukam K, Osazuwa E, Ahonkhai I, Ngwu M, Osemene G, Bruce AW, Reid G. Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Microbes Infect. 2006 May;8(6):1450-4. Epub 2006 Mar 29.

Austin J, Singhal N, Voigt R, Smaill F, Gill MJ, Walmsley S, Salit I, Gilmour J, Schlech WF 3rd, Choudhri S, Rachlis A, Cohen J, Trottier S, Toma E, Phillips P, Ford PM, Woods R, Singer J, Zarowny DP, Cameron DW; CTN 091/CRIT Cartenoids Study Group. A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome. Eur J Clin Nutr. 2006 Nov;60(11):1266-76. Epub 2006 May 24.

Bourre JM. Effects of nutrients (in food) on the structure and function of the nervous system: update on dietary requirements for brain. Part 1: micronutrients. J Nutr Health Aging. 2006 Sep-Oct;10(5):377-85. Review.

Cunningham-Rundles, S.,Ahrne, S. Bengmark, S. Johann-Liang, R. Marshall, F., Metakis,L, Califano, C.,Dunn, A., Grassey, C. Hinds, G. & Cervia, J. 2000 Probiotics and Immune Response, American Journal of Gastroenterology. 1 (95) 22-25

Field CJ, Johnson IR, Schley PD. Nutrients and their role in host resistance to infection. J Leukoc Biol. 2002 Jan;71(1):16-32. Review.

Hughes S, Kelly P. Interactions of malnutrition and immune impairment, with specific reference to immunity against parasites. Parasite Immunol. 2006 Nov;28(11):577-88. Review.

Kaiser JD, Campa AM, Ondercin JP, Leoung GS, Pless RF, Baum MK. Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy: a prospective, double-blinded, placebo-controlled trial. J Acquir Immune Defic Syndr. 2006 Aug 15;42(5):523-8.

Kim SO, Sheikh HI, Ha SD, Martins A, Reid G. G-CSF-mediated inhibition of JNK is a key mechanism for Lactobacillus rhamnosus-induced suppression of TNF production in macrophages. Cell Microbiol. 2006 Dec;8(12):1958-71. Epub 2006 Aug 2.

Olah A, Belagyi T, Issekutz A, Gamal ME, Bengmark S. Randomized clinical trial of specific lactobacillus and fibre supplement to early enteral nutrition in patients with acute pancreatitis. Br J Surg. 2002 Sep;89(9):1103-7.

Park S, Johnson MA. What is an adequate dose of oral vitamin B12 in older people with poor vitamin B12 status? Nutr Rev. 2006 Aug;64(8):373-8. Review.

Study ID Numbers:	R-07-220, 13468
First Received:	August 16, 2007
Last Updated:	September 27, 2007
ClinicalTrials.gov Identifier:	NCT00517803
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

micronutrients

immunodeficiency

probiotics

yogurt

Healthy

Acquired Immunodeficiency Syndrome

Complementary Therapies

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Neoplasms, Second Primary

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Healthy

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Neoplasms

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00517803