Soy Nut Study on Markers of Health

May 25, 2017 updated by: University of California, Davis

Effects of Soy on Metabolite Markers of Health

The investigators hope to learn about the effects of soy nuts on markers of health. When some people eat soy foods, their gut bacteria make equol. Equol is a soy metabolite (small molecule made during metabolism). The investigators will be testing blood samples to determine if markers of health are different for people who make equol versus people who do not make equol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to investigate the metabolomic response to consumption of soy protein containing polyphenolic phytochemicals (isoflavones). The aim of this pilot study is to demonstrate proof of concept and ability to detect metabolomic changes that are responsive to soy. This preliminary data will then be used to design future research projects.

Food phytochemicals such as the polyphenolic flavonoids from a wide variety of foods and beverages have been associated with cardiovascular protective effects in epidemiologic studies. Significant controversy exists in the literature regarding the efficacy and mechanisms for the cardiovascular protection of soy foods. The soy hypothesis for cardiovascular risk reduction has been focused mainly on the isoflavone content of soy, but uncertainty still exists regarding the bioactive component(s). In particular, consumption of soy protein foods has been associated with favorable cardiovascular disease (CVD) risk profiles in population based studies. Controlled clinical trials and meta-analyses however, have resulted in the conclusions that soy protein with associated isoflavones has only modest hypocholesterolemic effects in the range of 3-5% reduction in LDL-cholesterol. Additional cardioprotective effects have been demonstrated in clinical trials, promoting small but significant changes in vascular endothelial function and antioxidant protection. An important observation is that animal studies have shown reduction in atherosclerotic lesion size both with and without decreased blood lipid levels. These results taken together suggest that soy and soy phytochemicals can promote positive risk factors and outcomes by mechanisms in addition to, and other than lowering serum cholesterol levels. There is a need for greater understanding of the cellular and molecular mechanisms underlying the physiologic responses to isoflavones in the vascular compartment. Increasing evidence is emerging that biologically relevant concentrations of isoflavones may impact cell signaling processes in vascular and other tissues.

The large body of literature on human clinical trials of soy proteins and isoflavones has focused primarily on traditional lipid and lipoprotein parameters, biomarkers of CVD risk, and functional changes in endothelial function, platelet activation and total blood antioxidant capacity as described above. It is possible and likely that the effect of soy consumption on CVD risk is a net result of multiple subtle changes in metabolic pathways, vascular inflammatory responses and cell-signaling pathways which are not readily detected in healthy individuals. Since individuals with metabolic syndrome (MetS) present with many of the metabolic aberrations purported to be improved through soy food ingestion, these individuals may be an excellent study population in order to investigate the effects of a soy food intervention on metabolic markers of health. Equol is the end-product of daidzein biotransformation, and is produced only by some humans, resulting in a phenotypic characteristic in response to dietary soy. It is hypothesized by some researchers that the "equol producers" may have additional metabolic and phenotypic responses to soy which may help to explain some of the variances in the literature. Few investigators have examined this question in existing studies, with two reporting an association with outcomes and one no association. A recent study using microarray analysis of lymphocytes from postmenopausal women demonstrated differential gene expression in women who form equol compared to those who do not, suggesting that equol status may be an important modulator of responses to soy isoflavones. No studies have examined this question in a metabolomic investigation. This demonstrates a gap in the literature and provides an opportunity to contribute significant novel data using cutting-edge approaches.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Ragle Human Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Postmenopausal women
  • Men ages 45 or above

  • Blood pressure greater than or equal to 130/85 mmHg but not greater than 160/100 and meeting an additional 2 of the remaining 4 Metabolic syndrome diagnostic criteria as defined by NCEP ATP III:

    1. Elevated waist circumference: men equal to or greater than 40 inches, women equal to or greater than 35 inches
    2. Reduced HDL cholesterol: men less than 40 mg/dL, women less than 50 mg/dL
    3. Fasting glucose greater than or equal to 100 mg/dL
    4. Fasting blood triglycerides greater than or equal to 150 mg/dL but less than 400 mg/dL
  • Weight of at least 110 pounds

Exclusion Criteria:

  • Smokers
  • Chronic disease, such as diabetes, cancer, renal disease, and blood disorders
  • History of intestinal disorders, which affect absorption or transit, such as ulcerative colitis or crohns disease
  • Allergy to soy
  • Antioxidant supplement usage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Matched food
Control food (matched for calories and macronutrients) per day for 4 weeks
Other: Matched food
Control food (matched for calories and macronutrients) per day for 4 weeks
ACTIVE_COMPARATOR: Soy nuts
Oil roasted soy nuts with 101 milligrams of soy isoflavones per day for 4 weeks
Other: Soy nuts
Oil roasted soy nuts with 101 milligrams of soy isoflavones per day for 4 weeks
Other Names:
  • Genisoy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve lipid profile
Time Frame: After 4 week intervention
Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, apolipoproteinA1, apolipoproteinB100, apolipoproteinB100:apolipoproteinA1, urinary F2-isoprostane
After 4 week intervention
Increase endothelial function
Time Frame: After 4 week intervention
Brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry, blood pressure, endothelin-1
After 4 week intervention
Attenuate glycemic responses
Time Frame: After 4 week intervention
Fasting plasma glucose, insulin, fructosamine, homeostasis model assessment of insulin resistance
After 4 week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease inflammatory markers
Time Frame: After 4 week intervention
High sensitivity C reactive protein, vascular cell adhesion molecule-1, intercellular adhesion molecule-1
After 4 week intervention
Follow anthropometrics for stable weight
Time Frame: After 4 week intervention
Weight, height, body mass index, waist circumference, hip circumference, waist:hip ratio
After 4 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Francene M Steinberg, PhD, RD, UC Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (ESTIMATE)

August 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200715715-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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