Viewing Study NCT00517803



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Study NCT ID: NCT00517803
Status: COMPLETED
Last Update Posted: 2017-08-28
First Post: 2007-08-16

Brief Title: Micronutrient Supplemented Probiotic Yogurt for HIVAIDS and Other Immunodeficiencies
Sponsor: Lawson Health Research Institute
Organization: Lawson Health Research Institute

Study Overview

Official Title: Micronutrient Supplemented Probiotic Yogurt for HIVAIDS and Other Immunodeficiencies A Randomized Placebo-controlled Trial
Status: COMPLETED
Status Verified Date: 2017-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: We hypothesize that micronutrient fortified probiotic yogurt can improve nutritional status and enhance immunity parameters in subjects HIVAIDS 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 etal 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 etal 2006
Detailed Description: Drs Reid and Hekmat have recently developed a fermented milk product yogurt containing Lactobacillus GR-1 and RC-14 and concluded that such dairy products are suitable vehicles for these beneficial microorganisms Hekmat S Reid G 2006

The strains Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 have a proven efficacy to treat and protect against gastrointestinal and urogenital infections Anukam K et al 2006 2007 In one study the supplementation of yogurt with these probiotics was shown to eradicate diahrea and increase the CD4 T-lymphocyte counts in HIV subjects Anukam K etal 2006 HIV infected subjects often suffer diarrheal episodes and consequently experience malabsorption of certain nutrients Cunningham-Rundles 2000 A study conducted by Cunningham et al 2000 found that probiotic Lactobacillus plantarum 299 had a positive impact on the immunity of 1017 children and on the growth of all of the children who were HIV-positive

It is estimated that 75 percent of immune function is localized in the gastrointestinal tract which may explain why oral administration of probiotics is an excellent tool for immunomodulation Olah A et al 2002 In a study of 45 patients with acute pancreatitis 22 were given probiotic Lactobacillus plantarum 299 and 10g of oat fibre with regular enteral nutrition and 23 were given a placebo in the form of regular enteral nutrition Significantly fewer n1 versus n7 patients in the probioticfibre group experienced septic complications requiring surgery highlighting the safety and potential hospitalized benefits that could be accrued for critical care nutrition

A study has recently shown in 40 HIV-infected patients taking a stavudine andor didanosine-based HAART regimen plus micronutrients twice daily for twelve weeks that the absolute CD4 count increased by an average of 24 versus 0 in the placebo group p001 The mean HIV-1 RNA decreased in the micronutrient supplementation group Kaiser etal 2006 This is significant for the HIVAIDS pandemic in Africa and for the many people in Canada living with HIVAIDS In addition this may be related to other immunodeficiencies in hospitalized patients from chemotherapeutic and radiological treatments organ transplantation controlling diabetes and other chronic ailments

Clinical malnutrition is a heterogenous group of disorders including macronutrient deficiencies that lead to body cell mass depletion and micronutrient deficiencies and these often coexist with infectious and inflammatory processes HughesS Kelly P 2006 Diverse factors affect bioavailability such as the nutritional status of individuals the presence in the diet of substances which facilitate or inhibit its absorption interactions among micronutrients illnesses and chemical characteristics of the compound used for fortification There is good evidence that specific micronutrients particularly zinc and vitamin A influence immunity while iron supplementation is often not effective in Africa Hughes S Kelly P 2006

More than 20 of older adults may have marginal or frank vitamin B12 deficiency Park etal 2006 while folic acid is often deficient in children and reproductive aged females Glutamine arginine fatty acids and vitamin E provide additional benefits to immunocompromised persons or patients who suffer from various infections while long-chain polyunsaturated n-3 fatty acids vitamin E vitamin C selenium and nucleotides can modulate immunity to fight infection Field etal 2002 In order to produce energy the use of glucose by nervous tissue requires vitamin B1 this vitamin modulates cognitive performance especially in the elderly Vitamin B9 preserves brain during its development and memory during ageing Vitamin B6 is likely to benefit in treating premenstrual depression Vitamins B6 and B12 among others are directly involved in the synthesis of some neurotransmitters Bourre JM 2006 Thus three formulations added to L rhamnosus GR-2 supplemented yogurt will be tested at the Brescia College Tasting Centre where volunteers will score the products for taste and texture Hekmat S Reid G 2006

Thirty test subjects will be recruited during the first four months of the study for inclusion in a trial starting at the 4-6 month time-point with completion by 10-12 months A crossover study will be performed in London in which 10 HIV positive volunteers with CD4 counts between 200 and 400 on their standard treatment including Highly Active Antiretroviral Therapy and 10 subjects with Cancer who are in the recovery stages and not currently receiving chemotherapy or radiation therapy and 10 healthy adults aged 18-30 will randomly be assigned to receive one cup of Yogurts 1 2 or 3 and a control unsupplemented yogurt 4 daily for one month followed by a two week washout where no yogurt will be consumed then one month on the second yogurt two weeks off etc for 162 days Subjects will not be receiving antibiotics not have any mental illness that would affect compliance or not be requiring surgery during the study No restrictions will be placed on subjects continuing prescribed or other remedies but none will consume any other probiotic product during the study The volunteers will be gender matched and a randomization scheme will ensure that subjects are blinded and different yogurts are distributed at each time thus for example two subjects will receive yogurt 1 two yogurt 2 three yogurt 3 and three yogurt 4 on day sample day one The two week washout period will be used as probiotic organisms do not persist for longer than that Various measurements will be taken on the day of consuming the first and last batches of yogurt days 0 30 44 74 88 118 132 162 These will include weight height and from blood samples the CD4 count CBC levels of TNFα IL-12 IL-10 and G-CSF Kim etal 2006 liver function test AST ALT serum albumin total protein blood urea serum zinc levels serum selenium levels and HIV-1 RNA A linear analogue self-assessment tool will be used to assess the subjects energy levels daily activities and overall quality of life Kaiser etal 2006

The present project is an important step in developing new yogurts supplemented with micronutrients and probiotic lactobacilli for malnourished children adults and seniors in Canada as well as surgical transplant and hospitalized patients and HIVAIDS subjects in Canada and in Africa The following formulations will be used to supplement the yogurt

1 The Kaiser micronutrient formula 14 N-Acetyl cysteine NAC 300 mg Acetyl L-carnitine 250 mg Magnesium 925 mg Alpha lipoic Acid 100 mg Selenium 138 µg Beta carotene Vitamin A 5666 IU Zinc 24 mg Vitamin C 21 mg Copper 0225 mg Vitamin B1 03 mg Boron 05 mg Vitamin B2 03 mg Potassium 1200 mg Pantothenic acid 13 mg Iron 33 mg Niacinamide 38 mg Manganese 05 mg Inositol 15 mg Biotin 75 µg Vitamin B6 03 mg Chromium 75 µg Vitamin B12 06 µg Molybdenum 113 µg Vitamin D 52 IU Choline 1219 mg Vitamin E 57 IU Bioflavonoid complex 75 mg Folic acid 100 µg L-Glutamine 25 mg Betaine HCL 375 mg
2 A multi-component formula containing zinc 30mg vitamins A beta carotene 5666 IU C 21mg and E 57 IU selenium 138µg iron 33mg folic acid 100µg vitamin B12 06 µg vitamin B6 03 mg vitamin B1 03mg
3 A basic supplement containing zinc 30mg vitamins A 666 IU vitamin C 21mg and E 57 IU and folic acid 100µg and 16 mg docosahexaenoic acid DHA-Omega 3 Fatty Acid and 24mg eicosapentaenoic acid EPA-Omega 3 Fatty Acid Austin J etal 2006 Alan DD etal 2006

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
13468 None None None