HMS4: Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome

Sponsor

MetaProteomics LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01010841

Collaborator

University of Florida (Other), University of Connecticut (Other), University of California, Irvine (Other)

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Overweight Obesity Hypercholesterolemia	Dietary Supplement: UltraMealPlus 360 (Medical food) Other: Low-glycemic-load diet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low-glycemic-load diet Modified Mediterranean-style low-glycemic-load diet	Other: Low-glycemic-load diet Modified Mediterranean-style low-glycemic-load diet
Experimental: Low-glycemic-load diet + medical food Modified Mediterranean-style, low-glycemic-load diet + medical food	Dietary Supplement: UltraMealPlus 360 (Medical food) Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) Other Names: UltraMealPlus 360 Other: Low-glycemic-load diet Modified Mediterranean-style low-glycemic-load diet

Arm

Intervention/Treatment

Active Comparator: Low-glycemic-load diet

Modified Mediterranean-style low-glycemic-load diet

Other: Low-glycemic-load diet

Modified Mediterranean-style low-glycemic-load diet

Experimental: Low-glycemic-load diet + medical food

Modified Mediterranean-style, low-glycemic-load diet + medical food

Dietary Supplement: UltraMealPlus 360 (Medical food)

Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)

Other Names:

UltraMealPlus 360

Other: Low-glycemic-load diet

Modified Mediterranean-style low-glycemic-load diet

Outcome Measures

Primary Outcome Measures

TG-to-HDL ratio [Baseline, 8 weeks, 12 weeks]

Secondary Outcome Measures

Components of metabolic syndrome (TG, HDL, resolution of MetS) [Baseline, 8 weeks, 12 weeks]
Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score) [Baseline, 8 weeks, 12 weeks]
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]
Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1) [Baseline, 8 weeks, 12 weeks]
Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning) [Baseline, 8 weeks, 12 weeks]
Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires) [baseline, then every 2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Over the preceding 4 weeks, initiation or cessation of regular exercise
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
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
Over the preceding 4 weeks, regular use of Kaprex® or Kaprex AI® at least 3 days/week
Over the preceding 4 weeks, regular use of NSAIDs (i.e. ibuprofen, celecoxib, etc.) at least 3 days per week
Over the preceding 12 weeks, use of cholesterol lowering medications, either by prescription (statins, etc.) or over-the-counter (gugulipids, niacin, etc.)
Over the preceding 12 weeks, use of oral or injectable corticosteroids, such as prednisone
Current use of oral anticoagulants such as Coumadin or injectable anticoagulants such as Heparin or Low Molecular Weight Heparin
Use of electronic implants such as pacemakers, defibrillators, nerve stimulators
Allergy to one or more of the ingredients in the investigational products
Poorly controlled hypertension (blood pressure above 155/95)
History of significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment, etc.)
History of serious heart disease (heart attack, angina, cardiac surgery, arrhythmia, or congestive heart failure)
History of deep vein thrombosis or pulmonary embolus (blood clot to lungs)
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
History of eating disorder (anorexia nervosa or bulimia) in preceding 5 years
History of alcoholism or drug addiction in the preceding 5 years
History of serious mental illness
History of attempted suicide in past 10 years
Untreated endocrine, neurological, or infectious disorder
Diagnosis of Human Immunodeficiency Virus (HIV) or Acquired HIV (AIDS)
Current cancer or a history of cancer (except skin cancer)
Pregnancy or lactation
If female of childbearing potential, unwillingness to practice a reliable method of birth control (i.e. physical sperm barriers or hormonal therapies)
Any other sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI).

Physical and Laboratory Test Findings

TG ≥ 400 mg/dl
abnormal blood count (Hct < 30 or > 47%, WBC < 3,000 or > 12,000, platelets <140 or > 500)
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)
fasting glucose >150 mg/dL, serum calcium (>10.5 mg/dL), positive pregnancy test (ß-hCG in blood)