Gestational DiabetesEarly Phase 1NCT02806739
Soy Supplementation and Gestational Diabetes
A Early Phase 1 study testing Soy Group (Soy Protein + Isoflavones) in people with Gestational Diabetes, run by University of Massachusetts, Boston at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of randomizing pregnant women at high risk for gestational diabetes to a 24-week period of soy food consumption. This study will also examine the effects of soy protein and isoflavones on glucose metabolism and lipid levels among pregnant women at high risk for… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Soy Group (Soy Protein + Isoflavones)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2016
- Phase
- Early Phase 1
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >=18 years
- ≤ 18 weeks of pregnancy
- Singleton pregnancy
- Have at least one of the risk factors for GDM, including overweight (BMI ≥ 25 kg/m2) before this pregnancy, first-degree relative with type-2 diabetes mellitus (T2DM), abnormal glucose tolerance/GDM in previous pregnancy, and/or history of macrosomia (birth weight ≥ 4,000 gram) in previous pregnancy
- Being able and willing to give written informed consent.
Who cannot join
- Allergic to soy or milk products
- Current smoker
- Preexisting diabetes outside of pregnancy or other heath conditions that could affect glucose levels
- Chronic or serious medical conditions such as hypertension, heart disease, stroke, chronic renal or hepatic disease, or malignant disease (by self-report and medical record review)
- Use of medications that could interfere with insulin secretion or insulin sensitivity
- Weight loss during this pregnancy more than 10% of pre-pregnancy body weight
- Current severe nausea and/or vomiting (by self-report).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Soy Protein and Isoflavone Supplementation for Improved Glucose Metabolism and Lipid Profiles in Pregnant Women at High Risk for Gestational Diabetes Mellitus (GDM)
The purpose of this study is to assess the feasibility of randomizing pregnant women at high risk for gestational diabetes to a 24-week period of soy food consumption. This study will also examine the effects of soy protein and isoflavones on glucose metabolism and lipid levels among pregnant women at high risk for gestational diabetes, and on child's weight and height at birth and 6 weeks of life.
Read the detailed description
Evidence from animal studies, human observational studies, and some randomized controlled trials has suggested that soy protein and isoflavones have beneficial effects on lipid and glucose metabolism. Additionally, soy isoflavones can diffuse across the placenta, enter fetal circulation and potentially reduce the susceptibility to cardiometabolic disorders in adulthood. Given the high prevalence of GDM and its serious health consequences for women and their children, and likely health benefits of soy protein and isoflavones on a panel of metabolic parameters, the role of maternal supplementation of soy protein and isoflavones for prevention of GDM and/or minimization of GDM severity in mothers and for improving health indicators in their offspring merits investigation.
This study will provide new and essential information about the efficacy and feasibility of using soy-based whole foods to prevent and manage gestational diabetes development. This study will be a randomized, placebo-controlled trial. Forty pregnant women at high risk for gestational diabetes will be recruited from the obstetrics services at the Melrose Wakefield Hospital and Tufts Medical Center, and randomized to receive soy-based foods or minimize soy intake, from the 16th gestational week to birth. To measure participants' compliance with the treatment, the study will use three methods: (1) monthly telephone interview about adherence to the treatment; (2) daily soy food intake log; and (3) serum isoflavone concentrations. To evaluate the effects of soy supplementation on GDM, the study will collect blood samples to measure glucose, insulin, HbA1c, and lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol ). The study will also measure weight and body composition of participating pregnant women and the participants' respective children's weight, length and body composition.
- Conditions
- Gestational Diabetes
- Being tested
- Soy Group (Soy Protein + Isoflavones), Control Group (Minimize Soy Intake)
- Keywords
- Soy protein, isoflavones, gestational diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy Group (Soy Protein + Isoflavones)Dietary supplement
Women in the intervention group are asked to eat a combination of soy foods that contain about 25 grams of protein and 60-75 milligrams of isoflavones per day, from the 16th gestational week to birth. A registered dietitian will instruct them to incorporate the soy foods into their daily diet.
Control Group (Minimize Soy Intake)Dietary supplement
Women in the control group will be instructed by the dietitian how to avoid soy supplements and minimize soy intake.
| Study group | Role | What they receive |
|---|---|---|
| Soy Group (Soy Protein + Isoflavones) | Experimental | Intervention: Soy-based whole foods containing about 25 grams of soy protein and 60-75 mg isoflavones.
Intervention group will consume soy foods containing about 25 grams of soy protein and 60-75 mg isoflavones per day, from 16th gestational week to birth. Examples of soy foods that contain 25 grams of soy protein and 60-75mg isoflavones include: 2 cups of soy milk, or 12 ounces tofu, or a half cup of soy nuts. Women in the Soy Group will be instructed by a registered dietitian how to incorporate the soy foods into their daily diet. Receives: Dietary Supplement: Soy Group (Soy Protein + Isoflavones) |
| Control Group (Minimize Soy Intake) | Placebo comparator | Control Group will avoid soy supplements and minimize intake of soy foods. Receives: Dietary Supplement: Control Group (Minimize Soy Intake) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events That Are Related to Treatment
The first aim of this study is to determine the safety of soy supplementation during pregnancy. This will be assessed by the number of participants who reported adverse events that are related to the study treatment.
Measured: From enrollment through study completion, an average of 30 weeks or 210 days.
Secondary outcomes (8)
Effects of Soy Intake on Triglycerides (TG)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Triglycerides (TG) is one of the measurements of lipid metabolism.
Measured: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Total Cholesterol (TC)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Total cholesterol (TC) is a measurement of lipid metabolism.
Measured: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on High-density Lipoprotein Cholesterol (HDL-C)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. High-density lipoprotein cholesterol (HDL-C) is a measurement of lipid metabolism.
Measured: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Free Fatty Acid (FFA)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Free fatty acid (FFA) is a measurement of lipid metabolism.
Measured: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Fasting Glucose
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Fasting glucose is a measurement of glucose metabolism.
Measured: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Fasting Insulin
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Fasting insulin is a measurement of glucose metabolism.
Measured: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Hemoglobin A1c (HbA1c)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Hemoglobin A1c (HbA1c) is a measurement of glucose metabolism.
Measured: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on C-reactive Protein (CRP)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. C-reactive protein (CRP) is a measurement of inflammation.
Measured: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Tufts University, Hallmark Health System
- Responsible party
- Sponsor
- Investigators
- Ling Shi, PhD, Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806739
- Sponsor's protocol ID
- UL1TR000161
- Status last verified
- Oct 2016
- First submitted
- 22 Jan 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data (IPD) will be not shared. Data will be shared in aggregated way in publications and national conferences.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Soy Protein and Isoflavone Supplementation for Improved Glucose Metabolism and Lipid Profiles in Pregnant Women at High Risk for Gestational Diabetes Mellitus (GDM)
- ClinicalTrials.gov ID
- NCT02806739
- Acronym / sponsor ID
- UL1TR000161
- Conditions
- Gestational Diabetes
- Keywords
- Soy protein, isoflavones, gestational diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Tufts University, Hallmark Health System
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Jun 2016 (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 assess the feasibility of randomizing pregnant women at high risk for gestational diabetes to a 24-week period of soy food consumption. This study will also examine the effects of soy protein and isoflavones on glucose metabolism and lipid levels among pregnant women at high risk for gestational diabetes, and on child's weight and height at birth and 6 weeks of life.
Detailed description
Evidence from animal studies, human observational studies, and some randomized controlled trials has suggested that soy protein and isoflavones have beneficial effects on lipid and glucose metabolism. Additionally, soy isoflavones can diffuse across the placenta, enter fetal circulation and potentially reduce the susceptibility to cardiometabolic disorders in adulthood. Given the high prevalence of GDM and its serious health consequences for women and their children, and likely health benefits of soy protein and isoflavones on a panel of metabolic parameters, the role of maternal supplementation of soy protein and isoflavones for prevention of GDM and/or minimization of GDM severity in mothers and for improving health indicators in their offspring merits investigation.
This study will provide new and essential information about the efficacy and feasibility of using soy-based whole foods to prevent and manage gestational diabetes development. This study will be a randomized, placebo-controlled trial. Forty pregnant women at high risk for gestational diabetes will be recruited from the obstetrics services at the Melrose Wakefield Hospital and Tufts Medical Center, and randomized to receive soy-based foods or minimize soy intake, from the 16th gestational week to birth. To measure participants' compliance with the treatment, the study will use three methods: (1) monthly telephone interview about adherence to the treatment; (2) daily soy food intake log; and (3) serum isoflavone concentrations. To evaluate the effects of soy supplementation on GDM, the study will collect blood samples to measure glucose, insulin, HbA1c, and lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol ). The study will also measure weight and body composition of participating pregnant women and the participants' respective children's weight, length and body composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy Group (Soy Protein + Isoflavones) | Experimental | Dietary Supplement: Soy Group (Soy Protein + Isoflavones)Intervention: Soy-based whole foods containing about 25 grams of soy protein and 60-75 mg isoflavones. Intervention group will consume soy foods containing about 25 grams of soy protein and 60-75 mg isoflavones per day, from 16th gestational week to birth. Examples of soy foods that contain 25 grams of soy protein and 60-75mg isoflavones include: 2 cups of soy milk, or 12 ounces tofu, or a half cup of soy nuts. Women in the Soy Group will be instructed by a registered dietitian how to incorporate the soy foods into their daily diet. |
| Control Group (Minimize Soy Intake) | Placebo comparator | Dietary Supplement: Control Group (Minimize Soy Intake)Control Group will avoid soy supplements and minimize intake of soy foods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18 years
- ≤ 18 weeks of pregnancy
- Singleton pregnancy
- Have at least one of the risk factors for GDM, including overweight (BMI ≥ 25 kg/m2) before this pregnancy, first-degree relative with type-2 diabetes mellitus (T2DM), abnormal glucose tolerance/GDM in previous pregnancy, and/or history of macrosomia (birth weight ≥ 4,000 gram) in previous pregnancy
- Being able and willing to give written informed consent.
Key exclusion criteria (7 listed)
- Allergic to soy or milk products
- Current smoker
- Preexisting diabetes outside of pregnancy or other heath conditions that could affect glucose levels
- Chronic or serious medical conditions such as hypertension, heart disease, stroke, chronic renal or hepatic disease, or malignant disease (by self-report and medical record review)
- Use of medications that could interfere with insulin secretion or insulin sensitivity
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 Group (Soy Protein + Isoflavones)Women in the intervention group are asked to eat a combination of soy foods that contain about 25 grams of protein and 60-75 milligrams of isoflavones per day, from the 16th gestational week to birth. A registered dietitian will instruct them to incorporate the soy foods into their daily diet. | Dietary supplement | Soy Group (Soy Protein + Isoflavones) |
| Control Group (Minimize Soy Intake)Women in the control group will be instructed by the dietitian how to avoid soy supplements and minimize soy intake. | Dietary supplement | Control Group (Minimize Soy Intake) |
Primary outcome
Number of Participants With Adverse Events That Are Related to Treatment
Time frame: From enrollment through study completion, an average of 30 weeks or 210 days.
The first aim of this study is to determine the safety of soy supplementation during pregnancy. This will be assessed by the number of participants who reported adverse events that are related to the study treatment.
8 secondary outcomes
Effects of Soy Intake on Triglycerides (TG)
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Total Cholesterol (TC)
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Free Fatty Acid (FFA)
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Fasting Glucose
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Fasting Insulin
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Hemoglobin A1c (HbA1c)
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on C-reactive Protein (CRP)
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
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 27 Oct 2016.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be not shared. Data will be shared in aggregated way in publications and national conferences.
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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.
Ling Shi, PhD principal investigator
University of Massachusetts, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Soy Group (Soy Protein + Isoflavones) in people with Gestational Diabetes, run by University of Massachusetts, Boston 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 5 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 27 Oct 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants With Adverse Events That Are Related to Treatment (time frame: From enrollment through study completion, an average of 30 weeks or 210 days.). 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 27 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.