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

• ClinicalTrials.gov Identifier: NCT02180841
• Recruitment Status: Completed
• First Posted: July 3, 2014
• Last Update Posted: March 29, 2016
• Sponsor: Penn State University
• Collaborator: DuPont Nutrition and Health
• Information provided by (Responsible Party): Penny Kris-Etherton, Penn State University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Disease	Dietary Supplement: Soy Protein Powder (25g/d); Dietary Supplement: Placebo; Dietary Supplement: Soy Protein Powder (50g/d)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Official Title: Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
• Study Start Date: March 2014
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Soy 25g; Soy protein powder (25g/day)	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.
Experimental: Soy 50g; Soy protein powder 50 g/day	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.
Placebo Comparator: Control; Control powder	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.

Outcome Measures

Primary Outcome Measures :

1. HDL function (RCT) as measured by cholesterol efflux. [ Time Frame: Baseline ]
   Prior to start of intervention
2. HDL function (RCT) as measured by cholesterol efflux. [ Time Frame: Week 6 ]
   End of treatment 1
3. HDL function (RCT) as measured by cholesterol efflux. [ Time Frame: Week 14 ]
   End of treatment 2
4. HDL function (RCT) as measured by cholesterol efflux. [ Time Frame: Week 22 ]
   End of treatment 3

Secondary Outcome Measures :

1. HDL particle size [ Time Frame: Baseline ]
   Prior to start of intervention
2. HDL particle size [ Time Frame: Week 6 ]
   End of treatment 1
3. HDL particle size [ Time Frame: Week 14 ]
   End of treatment 2
4. HDL particle size [ Time Frame: Week 22 ]
   End of treatment 3

Other Outcome Measures:

1. Lipids (including lipoproteins and apolipoproteins) [ Time Frame: Baseline ]
   Prior to start of intervention
2. Lipids (including lipoproteins and apolipoproteins) [ Time Frame: Week 6 ]
   End of treatment 1
3. Lipids (including lipoproteins and apolipoproteins) [ Time Frame: Week 14 ]
   End of treatment 2
4. Lipids (including lipoproteins and apolipoproteins) [ Time Frame: Week 22 ]
   End of treatment 3
5. Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). [ Time Frame: Baseline ]
   Prior to start of intervention
6. Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). [ Time Frame: Week 6 ]
   End of treatment 1
7. Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). [ Time Frame: Week 14 ]
   End of treatment 2
8. Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). [ Time Frame: Week 22 ]
   End of treatment 3

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Penn State University

University Park, Pennsylvania, United States, 16802

Sponsors and Collaborators

Penn State University

DuPont Nutrition and Health

Investigators

• Principal Investigator: Penny M Kris-Etherton, PhD; Penn State University

More Information

• Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
• ClinicalTrials.gov Identifier: NCT02180841
• Other Study ID Numbers: PKE SOY
• First Posted: July 3, 2014
• Last Update Posted: March 29, 2016
• Last Verified: March 2016

Keywords provided by Penny Kris-Etherton, Penn State University:

soy; hypertension; HDL-C; cholesterol efflux; cardiovascular disease

Additional relevant MeSH terms:

Cardiovascular Diseases