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

Cardiovascular Disease Clinical Trial

— SOY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180841
• Other study ID #: PKE SOY
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Soy Protein Powder (25g/d)
Participants will consume 25g soy protein powder daily for a 6 week treatment period.
• Placebo
Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
• Soy Protein Powder (50g/d)
Participants will consume 50g soy protein powder daily for a 6 week treatment period.

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	DuPont Nutrition and Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipids (including lipoproteins and apolipoproteins)	Prior to start of intervention	Baseline
Other	Lipids (including lipoproteins and apolipoproteins)	End of treatment 1	Week 6
Other	Lipids (including lipoproteins and apolipoproteins)	End of treatment 2	Week 14
Other	Lipids (including lipoproteins and apolipoproteins)	End of treatment 3	Week 22
Other	Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).	Prior to start of intervention	Baseline
Other	Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).	End of treatment 1	Week 6
Other	Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).	End of treatment 2	Week 14
Other	Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).	End of treatment 3	Week 22
Primary	HDL function (RCT) as measured by cholesterol efflux.	Prior to start of intervention	Baseline
Primary	HDL function (RCT) as measured by cholesterol efflux.	End of treatment 1	Week 6
Primary	HDL function (RCT) as measured by cholesterol efflux.	End of treatment 2	Week 14
Primary	HDL function (RCT) as measured by cholesterol efflux.	End of treatment 3	Week 22
Secondary	HDL particle size	Prior to start of intervention	Baseline
Secondary	HDL particle size	End of treatment 1	Week 6
Secondary	HDL particle size	End of treatment 2	Week 14
Secondary	HDL particle size	End of treatment 3	Week 22