Cardiovascular DiseaseNCT02024906
Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants
A study testing soy protein isolate (SPI) and milk protein isolate (MPI) in people with Cardiovascular Disease and Subclinical Hypothyroid, run by Jill Hamilton-Reeves, PhD RD LD at 1 site in United States.
Trial summary
The purpose of this study is to help the researchers understand if using a soy supplement impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Cardiovascular Disease, Subclinical Hypothyroid
- What is being tested?
- soy protein isolate (SPI) and milk protein isolate (MPI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Sep 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with subclinical hypothyroidism (otherwise healthy volunteers)
- Adults aged 25 - 70 yrs.
- Willing to avoid consumption of soy/other isoflavone containing foods (i.e. some snack bars) during the study.
- Willing to avoid consumption of dietary (other than multivitamin) and herbal supplements during the study.
Who cannot join
- Taking drugs that interfere with thyroid function
- Planning pregnancy in the next 6 months
- Taking drugs that lower lipids, blood pressure, or sensitize insulin
- Regular consumption of soy products (>20 g/wk)
- Consumption of soyfoods within 90 days prior to enrollment.
- Known history of soy or milk allergy or intolerance.
- Taking antibiotics during the intervention
- Active viral infections such as Human immunodeficiency virus (HIV) positive or hepatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to help the researchers understand if using a soy supplement impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.
Read the detailed description
This pilot trial is a double blind, randomized, parallel arm trial. Eighty participants with subclinical hypothyroidism will be randomized to consume either soy protein isolate or milk protein isolate for 8 weeks.
- Conditions
- Cardiovascular Disease, Subclinical Hypothyroid
- Being tested
- soy protein isolate (SPI), milk protein isolate (MPI)
- Keywords
- isoflavone, CVD, soy intake, subclinical hypothyroid
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy protein isolate (SPI)Dietary supplement
milk protein isolate (MPI)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| soy protein isolate (SPI) | Experimental | 25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones Receives: Dietary Supplement: soy protein isolate (SPI) |
| milk protein isolate (MPI) | Active comparator | milk protein isolate (MPI) containing 0 mg/d isoflavones Receives: Dietary Supplement: milk protein isolate (MPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the cardiometabolic profile
Evaluate the role of isoflavone intake on cardiovascular disease.
Measured: Change from Baseline to Week 8
Secondary outcomes (3)
Change in thyroid function
Safety will be monitored through measuring thyroid stimulating hormone (TSH) and free thyroxine (T4) in participants while on the study.
Measured: Change from Basesline to 8 Weeks
Change in thyroid function
Safety will be monitored through measuring thyroid stimulating hormone (TSH) and free thyroxine (T4) in participants while on the study.
Measured: Change from Basesline to 4 Weeks
Changes in the cardiometabolic profile
Evaluate the role of isoflavone intake on cardiovascular disease.
Measured: Change from Basesline to 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jill Hamilton-Reeves, PhD RD LD
- Sponsor type
- University, hospital or other
- Collaborators
- Soy Nutrition Institute
- Responsible party
- Sponsor-investigator, Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center
- Investigators
- Jill Hamilton-Reeves, PhD, RD, LD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024906
- Sponsor's protocol ID
- STUDY00000073
- Other IDs
- UL1TR000001, HD002528
- Status last verified
- Sep 2015
- First submitted
- 27 Dec 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants
- ClinicalTrials.gov ID
- NCT02024906
- Acronym / sponsor ID
- STUDY00000073
- Conditions
- Cardiovascular Disease, Subclinical Hypothyroid
- Keywords
- isoflavone, CVD, soy intake, subclinical hypothyroid
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jill Hamilton-Reeves, PhD RD LDUniversity, hospital or other
- Collaborators
- Soy Nutrition Institute
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Dec 2013 (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 this study is to help the researchers understand if using a soy supplement impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.
Detailed description
This pilot trial is a double blind, randomized, parallel arm trial. Eighty participants with subclinical hypothyroidism will be randomized to consume either soy protein isolate or milk protein isolate for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soy protein isolate (SPI) | Experimental | Dietary Supplement: soy protein isolate (SPI)25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones |
| milk protein isolate (MPI) | Active comparator | Dietary Supplement: milk protein isolate (MPI)milk protein isolate (MPI) containing 0 mg/d isoflavones |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with subclinical hypothyroidism (otherwise healthy volunteers)
- Adults aged 25 - 70 yrs.
- Willing to avoid consumption of soy/other isoflavone containing foods (i.e. some snack bars) during the study.
- Willing to avoid consumption of dietary (other than multivitamin) and herbal supplements during the study.
Key exclusion criteria (8 listed)
- Taking drugs that interfere with thyroid function
- Planning pregnancy in the next 6 months
- Taking drugs that lower lipids, blood pressure, or sensitize insulin
- Regular consumption of soy products (>20 g/wk)
- Consumption of soyfoods within 90 days prior to enrollment.
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 isolate (SPI) | Dietary supplement | soy protein isolate (SPI) |
| milk protein isolate (MPI) | Dietary supplement | milk protein isolate (MPI) |
Primary outcome
Changes in the cardiometabolic profile
Time frame: Change from Baseline to Week 8
Evaluate the role of isoflavone intake on cardiovascular disease.
3 secondary outcomes
Change in thyroid function
Time frame: Change from Basesline to 8 Weeks
Change in thyroid function
Time frame: Change from Basesline to 4 Weeks
Changes in the cardiometabolic profile
Time frame: Change from Basesline to 4 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Jill Hamilton-Reeves, PhD, RD, LD principal investigator
University of Kansas Medical Center
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 isolate (SPI) and milk protein isolate (MPI) in people with Cardiovascular Disease and Subclinical Hypothyroid, run by Jill Hamilton-Reeves, PhD RD LD 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 23 Sep 2015. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in the cardiometabolic profile (time frame: Change from Baseline to Week 8). 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 23 Sep 2015.