NCT01010841

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: MetaProteomics LLC · Industry
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Syndrome
• Overweight
• Obesity
• Hypercholesterolemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2009-11-10
• Last updated: 2012-01-12

Locations

1 site across 1 country: United States