Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome

Obesity Clinical Trial

— HMS4  

Official title:

Multi-center, Randomized Intervention to Compare the Effects of 2 Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010841
• Other study ID #: HMS4-MUL-CT
• Status: Completed
• Phase: N/A
• First received: November 6, 2009
• Last updated: January 11, 2012
• Start date: August 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2012
• Source: MetaProteomics LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Overweight
• Syndrome

Intervention

Dietary Supplement:
• UltraMealPlus 360 (Medical food)
Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)

Other:
• Low-glycemic-load diet
Modified Mediterranean-style low-glycemic-load diet

Locations

Country	Name	City	State
United States	Mark McIntosh MD	Jacksonville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
MetaProteomics LLC	University of California, Irvine, University of Connecticut, University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (7)

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 — View 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 — View 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 w — View 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 i

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 wome — View 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 — View 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TG-to-HDL ratio		Baseline, 8 weeks, 12 weeks	No
Secondary	Components of metabolic syndrome (TG, HDL, resolution of MetS)		Baseline, 8 weeks, 12 weeks	No
Secondary	Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)		Baseline, 8 weeks, 12 weeks	No
Secondary	CVD risk factors (cholesterol, LDL, chol/HDL, apoAI, apoB, apoAII, apoCII, apoCIII, apoE, homocysteine, RBC fatty acids, Framingham risk score)		Baseline, 8 weeks, 12 weeks	No
Secondary	Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)		Baseline, 8 weeks, 12 weeks	No
Secondary	Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning)		Baseline, 8 weeks, 12 weeks	No
Secondary	Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)		baseline, then every 2 weeks	No