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

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Soy Protein Powder (25g/d); Dietary Supplement: Placebo; Dietary Supplement: Soy Protein Powder (50g/d)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02180841

PKE SOY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and Female
• 35-60 years old,with
• Systolic blood pressure greater than 120 mm Hg
• Diastolic blood pressure greater than 80 mm Hg
• BMI within 18-39 kg/m2 ,
• non smokers with
• no inflammatory diseases and
• not taking medication for high cholesterol, blood pressure, or glucose control

Exclusion criteria

• Under 35 years of age or over 60 years old
• Systolic blood pressure <120 or Diastolic blood pressure <80
• smoker
• inflammatory disease
• BMI outside of 18-39kg/m2 range
• taking medication
• refusal to discontinue any other supplement use

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 3 patient groups, including a placebo group

Soy 25g

Experimental group

Description:

Soy protein powder (25g/day)

Treatment:

Dietary Supplement: Soy Protein Powder (50g/d)

Dietary Supplement: Placebo

Dietary Supplement: Soy Protein Powder (25g/d)

Soy 50g

Experimental group

Description:

Soy protein powder 50 g/day

Treatment:

Dietary Supplement: Soy Protein Powder (50g/d)

Dietary Supplement: Placebo

Dietary Supplement: Soy Protein Powder (25g/d)

Control

Placebo Comparator group

Description:

Control powder

Treatment:

Dietary Supplement: Soy Protein Powder (50g/d)

Dietary Supplement: Placebo

Dietary Supplement: Soy Protein Powder (25g/d)