Protandim and the Metabolic Syndrome
![]() |
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: NCT01125501 |
Recruitment Status
:
Withdrawn
(funding not available)
First Posted
: May 18, 2010
Last Update Posted
: October 18, 2017
|
Sponsor:
SomaLogic, Inc.
Collaborator:
LifeVantage
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | May 17, 2010 | |||
First Posted Date ICMJE | May 18, 2010 | |||
Last Update Posted Date | October 18, 2017 | |||
Study Start Date ICMJE | April 2010 | |||
Estimated Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Measure Decrease in Oxidative Stress markers. [ Time Frame: every 30 days for 120 days ] the primary purpose of this trial is a preliminary study to examine the relationship to markers of oxidative stress,in response to Protandim, in Metabolic Syndrome.
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01125501 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Protein signatures [ Time Frame: every 30 days for 120 days ] evaluating the effects of Protandim on protein profile changes in patients with metabolic syndrome
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Protandim and the Metabolic Syndrome | |||
Official Title ICMJE | Protandim and the Metabolic Syndrome: A Preliminary Study to Define Protein Signatures That Change Along With Lowered Oxidative Stress Measured as F2 Isoprostanes or TBARS and Inflammation Measured as hsCRP | |||
Brief Summary | Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress. | |||
Detailed Description | Evaluate the effects of Protandim on protein profile changes and markers of inflammation and oxidation in subjects (40-60 years of age) with the Metabolic Syndrome. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
|||
Condition ICMJE | Metabolic Syndrome | |||
Intervention ICMJE | Dietary Supplement: Protandim
The product Protandim used in this study have ingredients derived from five botanical sources [Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)]. |
|||
Study Arms |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Estimated Enrollment ICMJE |
28 | |||
Estimated Study Completion Date | June 2010 | |||
Estimated Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
NCEP/ATP III criteria
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 40 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01125501 | |||
Other Study ID Numbers ICMJE | SomaL-028 (withdrawn) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Robert H. Eckel, MD; Professor of Medicine, Univeristy of Colorado Denver | |||
Study Sponsor ICMJE | SomaLogic, Inc. | |||
Collaborators ICMJE | LifeVantage | |||
Investigators ICMJE |
|
|||
PRS Account | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Verification Date | July 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |