Cardiovascular DiseaseSOYNCT02180841
Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
A study testing Soy Protein Powder (25g/d) and Soy Protein Powder (50g/d) in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Soy Protein Powder (25g/d) and Soy Protein Powder (50g/d)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
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.
Read the 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
- Being tested
- Soy Protein Powder (25g/d), Placebo, Soy Protein Powder (50g/d)
- Keywords
- soy, hypertension, HDL-C, cholesterol efflux, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy Protein Powder (25g/d)Dietary supplement
Participants will consume 25g soy protein powder daily for a 6 week treatment period.
PlaceboDietary supplement
Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
Soy Protein Powder (50g/d)Dietary supplement
Participants will consume 50g soy protein powder daily for a 6 week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Soy 25g | Experimental | Soy protein powder (25g/day) Receives: Dietary Supplement: Soy Protein Powder (25g/d); Dietary Supplement: Placebo; Dietary Supplement: Soy Protein Powder (50g/d) |
| Soy 50g | Experimental | Soy protein powder 50 g/day Receives: Dietary Supplement: Soy Protein Powder (25g/d); Dietary Supplement: Placebo; Dietary Supplement: Soy Protein Powder (50g/d) |
| Control | Placebo comparator | Control powder Receives: Dietary Supplement: Soy Protein Powder (25g/d); Dietary Supplement: Placebo; Dietary Supplement: Soy Protein Powder (50g/d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL function (RCT) as measured by cholesterol efflux.
Prior to start of intervention
Measured: Baseline
HDL function (RCT) as measured by cholesterol efflux.
End of treatment 1
Measured: Week 6
HDL function (RCT) as measured by cholesterol efflux.
End of treatment 2
Measured: Week 14
HDL function (RCT) as measured by cholesterol efflux.
End of treatment 3
Measured: Week 22
Secondary outcomes (4)
HDL particle size
Prior to start of intervention
Measured: Baseline
HDL particle size
End of treatment 1
Measured: Week 6
HDL particle size
End of treatment 2
Measured: Week 14
HDL particle size
End of treatment 3
Measured: Week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- DuPont Nutrition and Health
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180841
- Sponsor's protocol ID
- PKE SOY
- Acronym
- SOY
- Status last verified
- Aug 2023
- First submitted
- 23 Jun 2014
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
- ClinicalTrials.gov ID
- NCT02180841
- Acronym / sponsor ID
- SOY / PKE SOY
- Conditions
- Cardiovascular Disease
- Keywords
- soy, hypertension, HDL-C, cholesterol efflux, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- DuPont Nutrition and Health
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soy 25g | Experimental | Dietary Supplement: Soy Protein Powder (25g/d), Dietary Supplement: Placebo, Dietary Supplement: Soy Protein Powder (50g/d)Soy protein powder (25g/day) |
| Soy 50g | Experimental | Dietary Supplement: Soy Protein Powder (25g/d), Dietary Supplement: Placebo, Dietary Supplement: Soy Protein Powder (50g/d)Soy protein powder 50 g/day |
| Control | Placebo comparator | Dietary Supplement: Soy Protein Powder (25g/d), Dietary Supplement: Placebo, Dietary Supplement: Soy Protein Powder (50g/d)Control powder |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 ,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy Protein Powder (25g/d)Participants will consume 25g soy protein powder daily for a 6 week treatment period. | Dietary supplement | Control, Soy 25g, Soy 50g |
| PlaceboParticipants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period. | Dietary supplement | Control, Soy 25g, Soy 50g |
| Soy Protein Powder (50g/d)Participants will consume 50g soy protein powder daily for a 6 week treatment period. | Dietary supplement | Control, Soy 25g, Soy 50g |
Primary outcome
HDL function (RCT) as measured by cholesterol efflux.
Time frame: Baseline
Prior to start of intervention
HDL function (RCT) as measured by cholesterol efflux.
Time frame: Week 6
End of treatment 1
HDL function (RCT) as measured by cholesterol efflux.
Time frame: Week 14
End of treatment 2
HDL function (RCT) as measured by cholesterol efflux.
Time frame: Week 22
End of treatment 3
4 secondary outcomes
HDL particle size
Time frame: Baseline
HDL particle size
Time frame: Week 6
HDL particle size
Time frame: Week 14
HDL particle size
Time frame: Week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny M Kris-Etherton, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy Protein Powder (25g/d) and Soy Protein Powder (50g/d) in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDL function (RCT) as measured by cholesterol efflux. (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.