Protandim and the Metabolic Syndrome

SomaLogic

Status: Withdrawn

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Protandim

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01125501

SomaL-028 (withdrawn)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age = 40-60 years of age
• Meets at least 3 of the 5 criteria for the metabolic syndrome (as defined by NCEP/ATP III criteria)

NCEP/ATP III criteria

• Central obesity as measured by waist circumference:

  • Men - Greater than 40 inches
  • Women - Greater than 35 inches

• Fasting blood triglycerides greater than or equal to 150 mg/dL

• Blood HDL cholesterol:

  • Men - Less than 40 mg/dL
  • Women - Less than 50 mg/dL

• Blood pressure greater than or equal to 130/85 mmHg or on anti-hypertensive Rx

• Fasting glucose greater than or equal to 100 but < 125 mg/dL

Exclusion criteria

• Women taking hormone replacement therapy for post menopause
• Signs or symptoms of acute coronary syndrome
• History of congestive heart failure (prior myocardial infarction, coronary artery disease including stent placement, coronary artery bypass graft, EBCT calcium score of at least 100, or a positive stress test)
• Serum creatinine > 1.5 mg/dL, AST or ALT > 2 times ULN, HgA1c >6.5%, severely depressed or elevated blood cell lines, triglycerides > 500, TSH outside of normal range, elevated calcium, blood pressure > 160/100, urine protein > 30 ,g/dl.
• Concurrent medical conditions/illnesses in which expected life expectancy is 2 years or less and/or are likely to require frequent hospitalizations and treatment adjustments (e.g., cirrhosis, active malignancy, , or highly active rheumatologic condition, lupus, rheumatoid arthritis or chronic obstructive pulmonary disease and diabetes).
• Participation in any other investigational substance or medical device study within 30 days before this trial and/or participation in such entity during this trial.
• Known pregnancy.
• Supplementation with nutraceuticals or if so one month washout before initiating the study before initiating this trial.
• Taking statins or fibrates to lower cholesterol
• Inability or unwillingness to provide written informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Protandim

Active Comparator group

Description:

one capsule a day for 30 days of protandim given, followed by a wash out period.

Treatment:

Dietary Supplement: Protandim

Placebo

Placebo Comparator group

Description:

one capsule a day for 30 days will be given followed by a washout period.

Treatment:

Dietary Supplement: Protandim