Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
SOY
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 21, 2023
August 1, 2023
1.8 years
June 23, 2014
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
HDL function (RCT) as measured by cholesterol efflux.
Prior to start of intervention
Baseline
HDL function (RCT) as measured by cholesterol efflux.
End of treatment 1
Week 6
HDL function (RCT) as measured by cholesterol efflux.
End of treatment 2
Week 14
HDL function (RCT) as measured by cholesterol efflux.
End of treatment 3
Week 22
Secondary Outcomes (4)
HDL particle size
Baseline
HDL particle size
Week 6
HDL particle size
Week 14
HDL particle size
Week 22
Other Outcomes (8)
Lipids (including lipoproteins and apolipoproteins)
Baseline
Lipids (including lipoproteins and apolipoproteins)
Week 6
Lipids (including lipoproteins and apolipoproteins)
Week 14
- +5 more other outcomes
Study Arms (3)
Soy 25g
EXPERIMENTALSoy protein powder (25g/day)
Soy 50g
EXPERIMENTALSoy protein powder 50 g/day
Control
PLACEBO COMPARATORControl powder
Interventions
Participants will consume 25g soy protein powder daily for a 6 week treatment period.
Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
Participants will consume 50g soy protein powder daily for a 6 week treatment period.
Eligibility Criteria
You may qualify if:
- Male and Female
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penn State Universitylead
- DuPont Nutrition and Healthcollaborator
Study Sites (1)
Penn State University
University Park, Pennsylvania, 16802, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penny M Kris-Etherton, PhD
Penn State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2014
First Posted
July 3, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 21, 2023
Record last verified: 2023-08