None listed
Conditions
Brief summary
Numico Research has developed a food product which is available as a food bar and as a food powder that can be dissolved in water. The food product consists of a mix of ingredients, including special proteins, fats, vitamins, minerals and fibres. The special balance of these ingredients in the food product is expected to have a beneficial effect on the immune system. The purpose of the study is to determine the effect of the daily use of this food product for a period of one year among HIV positive adults. If the study results are favourable, the food product can be developed further to support the treatment of HIV positive patients.
Interventions
Nutrtional intervention study.
The purpose of the study is to determine the effect of daily use (twice a day at anytime) of a food product for a period of one year among HIV positive patients. The study will be carried out in approximately 10 countries and approximately 800 patients will participate. Half of the patients will receive the active food product and half will receive the control food product.
Nutrtional intervention study. The purpose of the study is to determine the effect of daily use (twice a day at anytime) of a food product for a period of one year among HIV positive patients. The study will be carried out in approximately 10 countries and approximately 800 patients will participate. Half of the patients will receive the active food product and half will receive the control food product. The food product consists of a mix of ingredients, including special proteins, fats, vitamins, minerals and fibres. Daily intake for the food products is as follows; Total fat 7.25g, Total protein 16.3g, Total carbohydrates 44.6g and oligosaccharides (soluble fibres) 15.0 g.
Sponsors
Royal Numico, Netherlands
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
HIV-1 positive adults who have not received highly active antiretroviral therapy ((HA)ART) in the past year and are not anticipated to start therapy within the next 6 months, HIV-1 infected for at least 6 months, HIV-1 RNA > 5,000 copies/ml, CD4+ T-cell count less than or equal to 800 cells/microlitre in the 3 months prior to screening.
Exclusion criteria
(HA)ART anticipated to be required within the first 6 months, allergy to milk and milk products, known diabetes mellitus type I or II, chronic renal disease requiring dialysis.
Outcome results
None listed