Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000925
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : July 29, 2013
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.


Condition or disease Intervention/treatment Phase
HIV Infections HIV Wasting Syndrome Drug: Optimune oral nutritional supplement Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
Study Start Date : May 1999
Actual Primary Completion Date : June 2003

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000925


Locations
Show Show 19 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Study Chair: Kathleen Mulligan, MD
Study Chair: Bruce R. Bistrian, MD
Study Chair: Fred R. Sattler, MD
Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000925    
Other Study ID Numbers: ACTG 392
11349 ( Registry Identifier: DAIDS-ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Dietary Proteins
HIV Wasting Syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Wasting Syndrome
Wasting Syndrome
Weight Loss
Cachexia
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Body Weight Changes
Body Weight
Emaciation
Metabolic Diseases
Nutrition Disorders