NCT01010841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

1.6 years

First QC Date

November 6, 2009

Last Update Submit

January 11, 2012

Conditions

Metabolic SyndromeOverweightObesityHypercholesterolemia

Keywords

Metabolic syndromeSerum lipidDietary interventionLifestyle modificationGlycemic loadPhytochemicalHopsAcaciaMediterranean dietKinase modulator

Outcome Measures

Primary Outcomes (1)

  • TG-to-HDL ratio

    Baseline, 8 weeks, 12 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Low-glycemic-load diet

ACTIVE COMPARATOR

Modified Mediterranean-style low-glycemic-load diet

Other: Low-glycemic-load diet

Low-glycemic-load diet + medical food

EXPERIMENTAL

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

Dietary Supplement: UltraMealPlus 360 (Medical food)Other: Low-glycemic-load diet

Interventions

UltraMealPlus 360 (Medical food)DIETARY_SUPPLEMENT

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

Also known as: UltraMealPlus 360
Low-glycemic-load diet + medical food
Low-glycemic-load dietOTHER

Modified Mediterranean-style low-glycemic-load diet

Low-glycemic-load dietLow-glycemic-load diet + medical food

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mark McIntosh MD

Jacksonville, Florida, 32209, United States

Location

Related Publications (7)

  • 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.

    PMID: 21600524RESULT

  • 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.

    PMID: 21286407RESULT

  • 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.

    PMID: 21481713RESULT

  • 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.

    PMID: 21775117RESULT

  • 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.

    PMID: 21944261RESULT

  • 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.

    PMID: 22024489RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Metabolic SyndromeOverweightObesityHypercholesterolemia

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Robert H Lerman, MD/PhD

    MetaProteomics LLC

    STUDY DIRECTOR

  • Mark McIntosh, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Maria Luz Fernandez, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

  • Wadie Najm, PhD

    University of California at Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 10, 2009

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

US(1)