HypercholesterolemiaNCT00175097
Soybean Based Diets and CVD Risk Factors
A study testing Diet: soybeans and products made thereof, Diet: soybean flour and products made thereof and Diet: soybean milk in people with Hypercholesterolemia, run by Tufts University at 2 sites in United States.
Trial summary
To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Diet: soybeans and products made thereof, Diet: soybean flour and products made thereof and Diet: soybean milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2001to May 2005
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plasma LDL-C >120mg/dL, Free from chronic illness, Not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin E, diuretics or hormones), Post-menopausal women.
Who cannot join
- Soy allergy, Smokers, Consuming >2 alcoholic drinks per day, Pre-menopausal women.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine
Boston, Massachusetts, 02111
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.
To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects.
Read the detailed description
Recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. This discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.The aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. The intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.
- Conditions
- Hypercholesterolemia
- Being tested
- Diet: soybeans and products made thereof, Diet: soybean flour and products made thereof, Diet: soybean milk, Diet: Animal protein based diet
- Keywords
- soy protein, lipids, lipoproteins, apolipoproteins, cholesterol, endothelial function
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet: soybeans and products made thereofOther
The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybeans and products made thereof.
Diet: soybean flour and products made thereofOther
The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean flour and products made thereof.
Diet: soybean milkOther
The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean milk.
Diet: Animal protein based dietOther
The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate animal protein.
| Study group | Role | What they receive |
|---|---|---|
| soybeans and products made thereof | Other | Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes \& grits) Receives: Other: Diet: soybeans and products made thereof |
| soybean flour and products made thereof | Other | Diet: soybean flour and products made thereof (textured soybean) Receives: Other: Diet: soybean flour and products made thereof |
| soybean milk | Other | Diet: soybean milk (tofu, soybean yogurt, cheese, etc.) Receives: Other: Diet: soybean milk |
| animal protein based diet | Other | Diet: animal protein based diet Receives: Other: Diet: Animal protein based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase
Measured: 24 weeks
Vascular endothelial function; end of each dietary phase
Measured: 24 weeks
Susceptibility of LDL to oxidation; end of each dietary phase
Measured: 24 weeks
C-reactive protein; end of each dietary phase
Measured: 24 weeks
Secondary outcomes (4)
Endogenous cholesterol synthesis; end of each dietary phase
Measured: 24 weeks
Endogenous triglyceride synthesis; end of each dietary phase
Measured: 24 weeks
Plasma and Urinary Isoflavone levels; end of each dietary phase
Measured: 24 weeks
Genotyping of candidate genes involved in the variability observed in response to dietary modification
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2001
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice H Lichtenstein, DSc, Principal investigator, Tufts University (HNRCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175097
- Sponsor's protocol ID
- HL 58008-1785
- Other IDs
- R01HL058008
- Status last verified
- Nov 2014
- First submitted
- 13 Sep 2005
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.
- ClinicalTrials.gov ID
- NCT00175097
- Acronym / sponsor ID
- HL 58008-1785
- Conditions
- Hypercholesterolemia
- Keywords
- soy protein, lipids, lipoproteins, apolipoproteins, cholesterol, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 15 Sep 2005 (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.
To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects.
Detailed description
Recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. This discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.The aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. The intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| soybeans and products made thereof | Other | Other: Diet: soybeans and products made thereofDiet: soybeans and products made thereof (soynuts, soynut butter, soy flakes \& grits) |
| soybean flour and products made thereof | Other | Other: Diet: soybean flour and products made thereofDiet: soybean flour and products made thereof (textured soybean) |
| soybean milk | Other | Other: Diet: soybean milkDiet: soybean milk (tofu, soybean yogurt, cheese, etc.) |
| animal protein based diet | Other | Other: Diet: Animal protein based dietDiet: animal protein based diet |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Plasma LDL-C >120mg/dL, Free from chronic illness, Not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin E, diuretics or hormones), Post-menopausal women.
Key exclusion criteria (1 listed)
- Soy allergy, Smokers, Consuming >2 alcoholic drinks per day, Pre-menopausal women.
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 |
|---|---|---|
| Diet: soybeans and products made thereofThe macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybeans and products made thereof. | Other | soybeans and products made thereof |
| Diet: soybean flour and products made thereofThe macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean flour and products made thereof. | Other | soybean flour and products made thereof |
| Diet: soybean milkThe macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean milk. | Other | soybean milk |
| Diet: Animal protein based dietThe macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate animal protein. | Other | animal protein based diet |
Primary outcome
Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase
Time frame: 24 weeks
Vascular endothelial function; end of each dietary phase
Time frame: 24 weeks
Susceptibility of LDL to oxidation; end of each dietary phase
Time frame: 24 weeks
C-reactive protein; end of each dietary phase
Time frame: 24 weeks
4 secondary outcomes
Endogenous cholesterol synthesis; end of each dietary phase
Time frame: 24 weeks
Endogenous triglyceride synthesis; end of each dietary phase
Time frame: 24 weeks
Plasma and Urinary Isoflavone levels; end of each dietary phase
Time frame: 24 weeks
Genotyping of candidate genes involved in the variability observed in response to dietary modification
Time frame: 24 weeks
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 2 Dec 2014.
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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.
Alice H Lichtenstein, DSc principal investigator
Tufts University (HNRCA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet: soybeans and products made thereof, Diet: soybean flour and products made thereof and Diet: soybean milk in people with Hypercholesterolemia, run by Tufts University at 2 sites 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 1 inclusion and 1 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase (time frame: 24 weeks). 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 2 Dec 2014.