Clinical trial NCT00000925: A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
Official title: Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
HIV Wasting Syndrome
Keywords: Dietary Proteins
HIV Wasting Syndrome
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass.

Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.

Detailed description: In many HIV-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein.

Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 18 years old.
* Have an HIV level less than 5,000 copies/ml within 30 days of study entry.
* Have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment.
* Are expected to live for at least 6 months.
* Are usually able to eat enough to maintain your present weight.
* Are able to complete a 3-day food diary.

Exclusion Criteria

You will not be eligible for this study if you:

* Have gained a significant amount of weight in the past 2 months.
* Have any opportunistic (HIV-associated) infections.
* Are unable to eat enough food for any reason, or are on tube feeding.
* Have nausea, diarrhea, or vomiting in the 14 days prior to study entry.
* Are being treated for diabetes.
* Are receiving chemotherapy or radiation therapy to treat cancer.
* Are pregnant or breast-feeding.
* Are allergic to milk or mangoes.
* Have an implanted defibrillator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univ of Southern California / LA County USC Med Ctr
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: Stanford
country: United States
facility: Stanford Univ Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Honolulu
country: United States
facility: Queens Med Ctr
state: Hawaii
city: Honolulu
country: United States
facility: Univ of Hawaii
state: Hawaii
city: New Orleans
country: United States
facility: Tulane Univ School of Medicine
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: St Louis
country: United States
facility: St Louis Regional Hosp / St Louis Regional Med Ctr
state: Missouri
city: New York
country: United States
facility: Chelsea Ctr
state: New York
city: New York
country: United States
facility: Cornell Univ Med Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: Univ of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Veterans Administration Med Ctr
state: Pennsylvania
city: West Columbia
country: United States
facility: Julio Arroyo
state: South Carolina
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
city: San Juan
country: Puerto Rico
facility: Univ of Puerto Rico
Study officials:
name: Kathleen Mulligan, MD
role: STUDY_CHAIR
name: Bruce R. Bistrian, MD
role: STUDY_CHAIR
name: Fred R. Sattler, MD
role: STUDY_CHAIR
References: