Whey protein for wasting

CTN79: Multicentre, Double-blind, randomized control study of whey protein concentrate vs. Casein in patients with AIDS and wasting syndrome


About the study: Treating AIDS-related wasting syndrome with a whey protein concentrate (WPC) may combat the negative effect of oxidative stress, improve T-cell function and T-cell survival, as well as aid in the control of HIV replication. The study's primary objectives are to determine the effect of WPC on nutrition in patients with AIDS-related wasting syndrome, and to determine the glutathione-changing activity of WPC in people with AIDS-related wasting syndrome. After a one-month screening period, each volunteer will be randomized to Diet Regimen A (WPC) or Diet Regimen B (casein - another milk product used as a control). Treatment will continue for six months. Researchers will monitor weight gain to judge the efficacy of the treatment.

About wasting syndrome: Involuntary weight loss (wasting) is one of the most common symptoms of HIV disease. Wasting can be caused by poor absorption of food, diarrhea, reduced food intake, or an increased metabolism (or all of the above). Wasting syndrome is clinically diagnosed with the involuntary loss of more than 10 percent of a person's body weight. Wasting can occur on a short term basis or become a chronic, on-going condition.

About the treatment: Whey protein is a milk product consisting of a group of proteins known to produce a substance (glutathione) which may improve the immune system and also slow the weight loss often experienced by people with AIDS.

"Whey to Go" from POZ Magazine (02/97) P. 102; Burroughs, Carola
Whey, a component of milk, is a popular diet supplement among AIDS patients because it improves weight gain and provides a protein-rich energy boost while containing little lactose. Laboratory studies have shown that a new whey protein concentrate, can inhibit HIV replication while also stimulating the production of glutathione, an amino acid that helps control progression of the virus. Small trials of the treatment in HIV-positive children and adults have demonstrated its benefit.


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NOTE: OTHER CRITERIA MAY BE APPLICABLE

Trial Type: Phase II/III

Form of drug: Powder


ENROLLMENT INFORMATION:

Enrollment: Now Enrolling

Enrollment to date:

Target enrollment: 60

PRINCIPAL INVESTIGATOR:

Dr. Richard Lalonde
Montreal Chest Hospital
514-8430-2090


SITE INVESTIGATORS:

Richard Lalonde
Montreal Chest Hospital Centre
514-843-2090

Emil Toma
Jewish General Hospital
514-843-2611

Toll-free Canadian HIV/AIDS Clinical Trials Information Line 1-800-661-4664