Clinical trial NCT01010841: Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome
Official title: Multi-center, Randomized Intervention to Compare the Effects of 2 Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Overweight
Obesity
Hypercholesterolemia
Keywords: Metabolic syndrome
Serum lipid
Dietary intervention
Lifestyle modification
Glycemic load
Phytochemical
Hops
Acacia
Mediterranean diet
Kinase modulator
Lead sponsor: MetaProteomics LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Florida
name: University of Connecticut
name: University of California, Irvine
First posted: 2009-11-10
Enrollment: 89
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to investigate from 3 sites (University of Connecticut, University of Florida, and University of California, Irvine) whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve cardiometabolic risk factors in women with metabolic syndrome.

Detailed description: As the worldwide dietary pattern becomes more westernized, the metabolic syndrome is reaching epidemic proportions. Lifestyle modifications including diet and exercise are recommended as first-line intervention for treating metabolic syndrome. Previously, we reported that specific phytochemical supplementation for 12 weeks (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins) increased the effectiveness of the modified Mediterranean-style low glycemic load dietary program on variables associated with metabolic syndrome and CVD in subjects with metabolic syndrome and elevated LDL cholesterol. In this study, we propose to conduct a multi-center randomized trial to confirm our previous findings.

Eligibility criteria: Inclusion Criteria:

* BMI ≥25 and \<45
* LDL \>100 mg/dl
* TG ≥150 and \<400 mg/dl
* meet 2 or more of the following 4 criteria:

  * HDL \<50 mg/dl
  * blood pressure ≥130/85 mmHg (or diagnosed hypertension on medication)
  * fasting glucose ≥100 mg/dl and \<150 mg/dl
  * waist circumference \>35 inches

Exclusion Criteria:

* Medical History and Concurrent Diseases

  1. Over the preceding 4 weeks, initiation or cessation of regular exercise
  2. Over the preceding 4 weeks, involvement in a significant diet or weight loss program such as Atkin's diet program, a very low calorie liquid program (such as Optifast, Medifast, and HMR), or any diet that has led to a weight loss of 10% of body weight over a period of 6 weeks
  3. Use of blood sugar lowering medications including thiazolidinedione class of oral medications including Avandia (rosiglitazone), Avandamet (metformin/rosiglitazone), Actos (pioglitazone), metformin (Glucophage, Fortamet, Riomet) or insulin over the preceding 12 weeks
  4. Over the preceding 4 weeks, regular use of Kaprex® or Kaprex AI® at least 3 days/week
  5. Over the preceding 4 weeks, regular use of NSAIDs (i.e. ibuprofen, celecoxib, etc.) at least 3 days per week
  6. Over the preceding 12 weeks, use of cholesterol lowering medications, either by prescription (statins, etc.) or over-the-counter (gugulipids, niacin, etc.)
  7. Over the preceding 12 weeks, use of oral or injectable corticosteroids, such as prednisone
  8. Current use of oral anticoagulants such as Coumadin or injectable anticoagulants such as Heparin or Low Molecular Weight Heparin
  9. Use of electronic implants such as pacemakers, defibrillators, nerve stimulators
  10. Allergy to one or more of the ingredients in the investigational products
  11. Poorly controlled hypertension (blood pressure above 155/95)
  12. History of significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment, etc.)
  13. History of serious heart disease (heart attack, angina, cardiac surgery, arrhythmia, or congestive heart failure)
  14. History of deep vein thrombosis or pulmonary embolus (blood clot to lungs)
  15. History of autoimmune diseases such as inflammatory bowel disease (Crohn's disease, and/or ulcerative colitis), multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, polymyositis, scleroderma and thyroiditis
  16. History of eating disorder (anorexia nervosa or bulimia) in preceding 5 years
  17. History of alcoholism or drug addiction in the preceding 5 years
  18. History of serious mental illness
  19. History of attempted suicide in past 10 years
  20. Untreated endocrine, neurological, or infectious disorder
  21. Diagnosis of Human Immunodeficiency Virus (HIV) or Acquired HIV (AIDS)
  22. Current cancer or a history of cancer (except skin cancer)
  23. Pregnancy or lactation
  24. If female of childbearing potential, unwillingness to practice a reliable method of birth control (i.e. physical sperm barriers or hormonal therapies)
  25. Any other sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI).
* Physical and Laboratory Test Findings

  1. TG ≥ 400 mg/dl
  2. abnormal blood count (Hct \< 30 or \> 47%, WBC \< 3,000 or \> 12,000, platelets \<140 or \> 500)
  3. abnormal kidney function test(s) (BUN \> 30 mg/dL or creatinine \> 1.5 mg/dL) or liver function test(s) (bilirubin total \> 2.0 mg/dL, ALT \> 75 IU/L, AST \> 75 IU/L; Alk Phos \> 130 IU)
  4. fasting glucose \>150 mg/dL, serum calcium (\>10.5 mg/dL), positive pregnancy test (ß-hCG in blood)

Primary outcomes:
measure: TG-to-HDL ratio
timeFrame: Baseline, 8 weeks, 12 weeks
Secondary outcomes:
measure: Components of metabolic syndrome (TG, HDL, resolution of MetS)
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)
timeFrame: Baseline, 8 weeks, 12 weeks
measure: CVD risk factors (cholesterol, LDL, chol/HDL, apoAI, apoB, apoAII, apoCII, apoCIII, apoE, homocysteine, RBC fatty acids, Framingham risk score)
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning)
timeFrame: Baseline, 8 weeks, 12 weeks
measure: Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)
timeFrame: baseline, then every 2 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mark McIntosh MD
state: Florida
Study officials:
affiliation: MetaProteomics LLC
name: Robert H Lerman, MD/PhD
role: STUDY_DIRECTOR
affiliation: University of Florida
name: Mark McIntosh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Connecticut
name: Maria Luz Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California at Irvine
name: Wadie Najm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones JL, Fernandez ML, McIntosh MS, Najm W, Calle MC, Kalynych C, Vukich C, Barona J, Ackermann D, Kim JE, Kumar V, Lott M, Volek JS, Lerman RH. A Mediterranean-style low-glycemic-load diet improves variables of metabolic syndrome in women, and addition of a phytochemical-rich medical food enhances benefits on lipoprotein metabolism. J Clin Lipidol. 2011 May-Jun;5(3):188-196. doi: 10.1016/j.jacl.2011.03.002. Epub 2011 Mar 11.
citation: Fernandez ML, Jones JJ, Ackerman D, Barona J, Calle M, Comperatore MV, Kim JE, Andersen C, Leite JO, Volek JS, McIntosh M, Kalynych C, Najm W, Lerman RH. Low HDL cholesterol is associated with increased atherogenic lipoproteins and insulin resistance in women classified with metabolic syndrome. Nutr Res Pract. 2010 Dec;4(6):492-8. doi: 10.4162/nrp.2010.4.6.492. Epub 2010 Dec 28.
citation: Ackermann D, Jones J, Barona J, Calle MC, Kim JE, LaPia B, Volek JS, McIntosh M, Kalynych C, Najm W, Lerman RH, Fernandez ML. Waist circumference is positively correlated with markers of inflammation and negatively with adiponectin in women with metabolic syndrome. Nutr Res. 2011 Mar;31(3):197-204. doi: 10.1016/j.nutres.2011.02.004.
citation: Barona J, Jones JJ, Kopec RE, Comperatore M, Andersen C, Schwartz SJ, Lerman RH, Fernandez ML. A Mediterranean-style low-glycemic-load diet increases plasma carotenoids and decreases LDL oxidation in women with metabolic syndrome. J Nutr Biochem. 2012 Jun;23(6):609-15. doi: 10.1016/j.jnutbio.2011.02.016. Epub 2011 Jul 19.
citation: Jones JL, Comperatore M, Barona J, Calle MC, Andersen C, McIntosh M, Najm W, Lerman RH, Fernandez ML. A Mediterranean-style, low-glycemic-load diet decreases atherogenic lipoproteins and reduces lipoprotein (a) and oxidized low-density lipoprotein in women with metabolic syndrome. Metabolism. 2012 Mar;61(3):366-72. doi: 10.1016/j.metabol.2011.07.013. Epub 2011 Sep 23.
citation: Jones JL, Park Y, Lee J, Lerman RH, Fernandez ML. A Mediterranean-style, low-glycemic-load diet reduces the expression of 3-hydroxy-3-methylglutaryl-coenzyme A reductase in mononuclear cells and plasma insulin in women with metabolic syndrome. Nutr Res. 2011 Sep;31(9):659-64. doi: 10.1016/j.nutres.2011.08.011.
citation: Jones JL, Ackermann D, Barona J, Calle M, Andersen C, Kim JE, Volek JS, McIntosh M, Najm W, Lerman RH, Fernandez ML. A Mediterranean low-glycemic-load diet alone or in combination with a medical food improves insulin sensitivity and reduces inflammation in women with metabolic syndrome. British Journal of Medicine & Medical Research 1(4):356-370, 2011.