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HypercholesterolemiaSOY-LDLNCT01547585

A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy

A study testing Standardized soy containing muffin in people with Hypercholesterolemia and Cardiovascular Disease, run by Guelph Food Research Centre at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is being conducted to test the hypothesis that daily consumption of a baked food product containing whole soy for 6 weeks will significantly reduce plasma Low Density Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hypercholesterolemia, Cardiovascular Disease, CRP
What is being tested?
Standardized soy containing muffin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
243 participants
Where
3 sitesCanada
Study dates
May 2012to Oct 2013
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 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males and females (not pregnant or lactating) aged 30-70 year
  • Body mass index (BMI) ≤40kg/m² and ≥18.5kg/m²
  • Fasting plasma total cholesterol ≥5.0
  • Fasting plasma LDL cholesterol ≥3.0 and <5.0 mmol/L.

Who cannot join

  • Fasting plasma triglycerides ≥4.0 mmol/L
  • Abnormal liver and kidney function
  • Unstable body weight(>3kg change in 3 months) or intention to lose or gain weight;
  • Diabetes mellitus (fasting plasma glucose ≥7.0 mmol/L or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
  • Use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
  • Major surgical or medical events within the past 3 months;
Show all 12Show fewer
  • Presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
  • Consumption of a diet containing ≥15% of energy from saturated fat;
  • Any food allergy or aversion or unwillingness to eat wheat, soy or milk;
  • Consumption of ≥5 servings per week of soy based food products;
  • Consumption of an average of >2 alcoholic beverages per day;
  • Regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Human Nutraceutical Research Unit. University of Guelph

    Guelph, Ontario, N1G 2W1

  • Glycemic Index Laboratories, Inc

    Toronto, Ontario, M5C 2N8

  • Canadian Centre for Agri-food Research in Health and Medicine

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: A Randomized Controlled Trial to Determine the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Whole Soy: a Dose Response Study

This study is being conducted to test the hypothesis that daily consumption of a baked food product containing whole soy for 6 weeks will significantly reduce plasma Low Density Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall goals of this study are to determine whether daily consumption of muffins made from whole soy flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and physical characterization of certified defatted whole soy flour that will be incorporated into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical trial. All participants will be randomized into one of three groups and asked to eat two muffins daily for 6 weeks in the following combination: high dose soy; control group or low dose soy. Before, after, and mid-way during the feeding period, blood samples will be obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals. The effect of soy consumption on waist circumference, body mass index (BMI) and blood pressure will also be examined.

Being tested
Standardized soy containing muffin
Keywords
Cholesterol, Cardiovascular disease, Soy, Dose-response
Medical subject headings
Hypercholesterolemia, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized soy containing muffinOther

    Also called Soy containing muffins

    Standardized muffin containing two levels of soy

Study groups in NCT01547585
Study groupRoleWhat they receive
ControlPlacebo comparator- Isocaloric control muffins
Receives: Other: Standardized soy containing muffin
Low Dose SoyExperimental- Isocaloric muffins containing low dose of soy
Receives: Other: Standardized soy containing muffin
High Dose SoyExperimental- Isocaloric muffins containing high dose soy
Receives: Other: Standardized soy containing muffin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Low Density Lipoprotein Cholesterol (LDL-Cholesterol)

    Measured: 6 weeks

Secondary outcomes (1)

  1. high sensitivity c-reactive protein (hsCRP)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionSep 2013
  4. Study completionOct 2013

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01547585
Sponsor's protocol ID
SOY-CVD-2012
Other IDs
RBPI#1746
Acronym
SOY-LDL
Status last verified
Mar 2015
First submitted
5 Mar 2012
Last updated
17 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Reinwald S, Akabas SR, Weaver CM. Whole versus the piecemeal approach to evaluating soy. J Nutr. 2010 Dec;140(12):2335S-2343S. doi: 10.3945/jn.110.124925. Epub 2010 Oct 27.

    PubMed 20980652

  • Zhang X, Shu XO, Gao YT, Yang G, Li Q, Li H, Jin F, Zheng W. Soy food consumption is associated with lower risk of coronary heart disease in Chinese women. J Nutr. 2003 Sep;133(9):2874-8. doi: 10.1093/jn/133.9.2874.

    PubMed 12949380

  • Kokubo Y, Iso H, Ishihara J, Okada K, Inoue M, Tsugane S; JPHC Study Group. Association of dietary intake of soy, beans, and isoflavones with risk of cerebral and myocardial infarctions in Japanese populations: the Japan Public Health Center-based (JPHC) study cohort I. Circulation. 2007 Nov 27;116(22):2553-62. doi: 10.1161/CIRCULATIONAHA.106.683755. Epub 2007 Nov 19.

    PubMed 18025534

  • Nanri A, Mizoue T, Takahashi Y, Kirii K, Inoue M, Noda M, Tsugane S. Soy product and isoflavone intakes are associated with a lower risk of type 2 diabetes in overweight Japanese women. J Nutr. 2010 Mar;140(3):580-6. doi: 10.3945/jn.109.116020. Epub 2010 Jan 6.

    PubMed 20053935

  • Yang B, Chen Y, Xu T, Yu Y, Huang T, Hu X, Li D. Systematic review and meta-analysis of soy products consumption in patients with type 2 diabetes mellitus. Asia Pac J Clin Nutr. 2011;20(4):593-602.

    PubMed 22094845

  • Anderson JW, Bush HM. Soy protein effects on serum lipoproteins: a quality assessment and meta-analysis of randomized, controlled studies. J Am Coll Nutr. 2011 Apr;30(2):79-91. doi: 10.1080/07315724.2011.10719947.

    PubMed 21730216

  • Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995 Aug 3;333(5):276-82. doi: 10.1056/NEJM199508033330502.

    PubMed 7596371

  • Zhan S, Ho SC. Meta-analysis of the effects of soy protein containing isoflavones on the lipid profile. Am J Clin Nutr. 2005 Feb;81(2):397-408. doi: 10.1093/ajcn.81.2.397.

    PubMed 15699227

  • Dewell A, Hollenbeck PL, Hollenbeck CB. Clinical review: a critical evaluation of the role of soy protein and isoflavone supplementation in the control of plasma cholesterol concentrations. J Clin Endocrinol Metab. 2006 Mar;91(3):772-80. doi: 10.1210/jc.2004-2350. Epub 2005 Dec 29.

    PubMed 16384855

  • Sirtori CR, Eberini I, Arnoldi A. Hypocholesterolaemic effects of soya proteins: results of recent studies are predictable from the anderson meta-analysis data. Br J Nutr. 2007 May;97(5):816-22. doi: 10.1017/S0007114507670810.

    PubMed 17408521

  • Sacks FM, Lichtenstein A, Van Horn L, Harris W, Kris-Etherton P, Winston M; American Heart Association Nutrition Committee. Soy protein, isoflavones, and cardiovascular health: an American Heart Association Science Advisory for professionals from the Nutrition Committee. Circulation. 2006 Feb 21;113(7):1034-44. doi: 10.1161/CIRCULATIONAHA.106.171052. Epub 2006 Jan 17.

    PubMed 16418439

  • Klein MA, Nahin RL, Messina MJ, Rader JI, Thompson LU, Badger TM, Dwyer JT, Kim YS, Pontzer CH, Starke-Reed PE, Weaver CM. Guidance from an NIH workshop on designing, implementing, and reporting clinical studies of soy interventions. J Nutr. 2010 Jun;140(6):1192S-1204S. doi: 10.3945/jn.110.121830. Epub 2010 Apr 14.

    PubMed 20392880

  • Padhi EM, Blewett HJ, Duncan AM, Guzman RP, Hawke A, Seetharaman K, Tsao R, Wolever TM, Ramdath DD. Whole Soy Flour Incorporated into a Muffin and Consumed at 2 Doses of Soy Protein Does Not Lower LDL Cholesterol in a Randomized, Double-Blind Controlled Trial of Hypercholesterolemic Adults. J Nutr. 2015 Dec;145(12):2665-74. doi: 10.3945/jn.115.219873. Epub 2015 Oct 7.

    PubMed 26446482

Questions about this trial

What is this clinical trial studying?

A study testing Standardized soy containing muffin in people with Hypercholesterolemia and Cardiovascular Disease, run by Guelph Food Research Centre at 3 sites in Canada.

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 12 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. 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?

Low Density Lipoprotein Cholesterol (LDL-Cholesterol) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01547585, which also lists 13 linked publications.

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 17 Mar 2015.

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