Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000925
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
1999-11-02
Brief Title:
A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
Status:
COMPLETED
Status Verified Date:
2013-07
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:
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 andor gain weight
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 andor 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 15 to 20 gkgday 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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11349 | REGISTRY | DAIDS-ES | None |