NCT02180841

Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle size and HDL function), central blood pressure, and indices of arterial stiffness.

Detailed description

The investigators propose to conduct a randomized three-period, crossover study to evaluate the effect of soy protein supplementation on HDL function. To ensure that there are no effects of treatment order on outcome measures, subjects will be randomized to a treatment sequence. Healthy males and females (n = 20; 35 to 60 years of age) with systolic blood pressure greater than 120 mm Hg and/or diastolic blood pressure greater than 80 mm Hg will be recruited for this study. Subjects will undergo 3 treatment periods in random order. These treatment periods will include: A) 25 g/d soy protein powder; B) 50 g/d soy protein powder; C) 0 g/d protein powder (control). Each treatment will be provided for 6 weeks separated by a 2-week break between treatment periods. All subjects will be encouraged to maintain body weight and physical activity levels during the study.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soy Protein Powder (25g/d)	Participants will consume 25g soy protein powder daily for a 6 week treatment period.
DIETARY_SUPPLEMENT	Placebo	Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
DIETARY_SUPPLEMENT	Soy Protein Powder (50g/d)	Participants will consume 50g soy protein powder daily for a 6 week treatment period.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-07-03
• Last updated: 2023-08-21

Locations

1 site across 1 country: United States