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Enrollment and study activities were suspended due to COVID-19.
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Genistein is a natural supplement that comes from soy. The purpose of this study is to see if genistein has any effect on preventing or reducing heart disease and diabetes risk in men receiving Androgen Deprivation Therapy for prostate cancer. A combination of nutritional measures, blood markers and imaging tools will assess body composition, lipid levels and insulin resistance. Information from this pilot study will increase understanding of interventions which may prevent or reduce health risks during prostate cancer treatment. This project involves 24 men who will receive androgen deprivation therapy for prostate cancer.
This is a double-blind, randomized, placebo-controlled trial of daily oral genistein in 24 men initiating Androgen Deprivation Therapy (ADT) for prostate cancer (PCa). Genistein is a natural supplement that comes from soy. The purpose of this study is to see if genistein has any effect on preventing or reducing heart disease and diabetes risk in men receiving ADT for PCa. A combination of nutritional measures, blood markers and imaging tools will assess body composition, lipid levels and insulin resistance. Information from this study will increase understanding of interventions which may prevent or reduce health risks during prostate cancer treatment.
All participants will receive standard counseling for diet and exercise by their oncology care team. Participants will be asked to withhold from any additional dietary supplements (with the exception of 1 standard daily multivitamin) during the study period. Participants will also be asked to complete a food diary for three days (on two weekdays and 1 weekend day).
Subjects will be randomized and stratified by diabetes status to either 60 mg/day oral genistein (30 mg taken twice daily), or matching placebo. The goal for randomizing based on diabetes status is to ensure approximately the same number of subjects who have diabetes and do not have diabetes receive genistein and placebo.
During follow-up, subjects will receive weekly reminders via phone call, text, or email to enhance compliance and monitor for potential adverse events. The 3-month study visit will be scheduled to coincide with the subject's standard of care follow-up visit. Three-month assessments will be the same as baseline assessments.
Investigators seek to assess indexes of insulin dynamics (insulin sensitivity and secretion) determined from an oral glucose tolerance test before and 12 weeks after a daily genistein or placebo supplement. Measures of vascular function before and 12 weeks after a daily genistein or placebo supplement will also be assessed via ultrasound along with other metabolic measures via blood draw.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genistein | Experimental | Participants with and without diabetes will receive 60 mg/day oral genistein (30 mg taken twice daily) for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants with and without diabetes will receive placebo taken twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genistein | Drug | Genistein is a natural supplement that comes from soy. Genistein will be taken orally (30 mg twice daily) for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline | The Matsuda index is a measurement of insulin sensitivity from plasma glucose and insulin concentrations during the oral glucose tolerance test (OGTT). Insulin sensitivity was calculated at baseline and after 8 weeks with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. Higher values are reflective of better insulin sensitivity. This test is not used to clinically diagnose disease, and there is no accepted, standard cutoff to define impaired insulin sensitivity or insulin resistance based on this index. | Baseline, Week 8 post-baseline |
| β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline | β-cell insulin secretion was determined from the OGTT. It is calculated as the ratio of the change in insulin values over the first 30 minutes of the OGTT and the change in glucose values over the first 30 minutes. Higher values are reflective of higher insulin secretion. This test is not used to clinically diagnose disease, and there is no accepted, standard cutoff to define impaired insulin secretion based on this index. | Baseline, Week 8 post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Stiffness | Arterial stiffness will be assessed by applanation tonometry. Results will be reported in m/s (meters/seconds). A higher value indicates a worse outcome. | Baseline, Week 8 |
| Vascular Endothelial Function at Baseline and Week 8 Post-baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Alvarez, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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Participants were enrolled between October 2017 and March 2021. 10 participants consented to take part in the study and 2 withdrew at some point in the study. Results are presented on all data provided by all participants before withdrawal, where applicable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Genistein | Participants with and without diabetes received 60 mg/day oral genistein (30 mg taken twice daily). Genistein: Genistein is a natural supplement that comes from soy. Genistein was taken orally (30 mg twice daily). Treatment was intended for 12 weeks but due to study termination treatment only lasted up to 8 weeks. |
| FG001 | Placebo | Participants with and without diabetes received placebo taken twice daily. Placebo: A placebo pill was taken orally. Treatment was intended for 12 weeks but due to study termination treatment only lasted up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Genistein | Participants with and without diabetes received 60 mg/day oral genistein (30 mg taken twice daily). Genistein: Genistein is a natural supplement that comes from soy. Genistein was taken orally (30 mg twice daily). Treatment was intended for 12 weeks but due to study termination treatment only lasted up to 8 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline | The Matsuda index is a measurement of insulin sensitivity from plasma glucose and insulin concentrations during the oral glucose tolerance test (OGTT). Insulin sensitivity was calculated at baseline and after 8 weeks with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. Higher values are reflective of better insulin sensitivity. This test is not used to clinically diagnose disease, and there is no accepted, standard cutoff to define impaired insulin sensitivity or insulin resistance based on this index. | Number of patients included only subjects that were able to complete the outcome assessment in each visit. | Posted | Median | Inter-Quartile Range | index | Baseline, Week 8 post-baseline |
|
Adverse events (AEs) were monitored weekly throughout the 8 weeks that participants were enrolled in the study.
AEs were defined as undesirable medical events or experiences, and classified as "expected", "unanticipated", or "serious" adverse events. Serious adverse events (SAEs) were predefined as experiences that suggest a significant hazard, such as events which: a) are fatal, b) are life-threatening, c) result in permanent disability, d) require inpatient hospitalization, or e) involve cancer, a congenital anomaly, or drug overdose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genistein | Participants with and without diabetes received 60 mg/day oral genistein (30 mg taken twice daily). Genistein: Genistein is a natural supplement that comes from soy. Genistein was taken orally (30 mg twice daily). Treatment was intended for 12 weeks but due to study termination treatment only lasted up to 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Alvarez | Emory University | 404-727-1390 | jessica.alvarez@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2020 | Jul 5, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Placebo | Drug | A placebo pill will be taken orally for 12 weeks. |
|
Vascular endothelial function was measured with flow-mediated dilation (FMD in %) via ultrasound. A lower FMD indicates a worse outcome. |
| Baseline, Week 8 post-baseline |
| Placebo |
Participants with and without diabetes received placebo taken twice daily. Placebo: A placebo pill was taken orally. Treatment was intended for 12 weeks but due to study termination treatment only lasted up to 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Participants with and without diabetes received placebo taken twice daily. Placebo: A placebo pill was taken orally. Treatment was intended for 12 weeks but due to study termination treatment only lasted up to 8 weeks. |
|
|
| Primary | β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline | β-cell insulin secretion was determined from the OGTT. It is calculated as the ratio of the change in insulin values over the first 30 minutes of the OGTT and the change in glucose values over the first 30 minutes. Higher values are reflective of higher insulin secretion. This test is not used to clinically diagnose disease, and there is no accepted, standard cutoff to define impaired insulin secretion based on this index. | Number of patients included only subjects that were able to complete the outcome assessment in each visit. | Posted | Median | Inter-Quartile Range | index | Baseline, Week 8 post-baseline |
|
|
|
| Secondary | Arterial Stiffness | Arterial stiffness will be assessed by applanation tonometry. Results will be reported in m/s (meters/seconds). A higher value indicates a worse outcome. | Number of patients included only subjects that were able to complete the outcome assessment in each visit. | Posted | Median | Inter-Quartile Range | m/s | Baseline, Week 8 |
|
|
|
| Secondary | Vascular Endothelial Function at Baseline and Week 8 Post-baseline | Vascular endothelial function was measured with flow-mediated dilation (FMD in %) via ultrasound. A lower FMD indicates a worse outcome. | Number of patients included only subjects that were able to complete the outcome assessment in each visit. | Posted | Median | Inter-Quartile Range | percentage of FMD | Baseline, Week 8 post-baseline |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Placebo | Participants with and without diabetes received placebo taken twice daily. Placebo: A placebo pill was taken orally. Treatment was intended for 12 weeks but due to study termination treatment only lasted up to 8 weeks. | 0 | 4 | 0 | 4 | 4 | 4 |
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Localized edema in feet and ankles | General disorders | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Heat strokes | General disorders | Non-systematic Assessment |
|
| Swollen ankles | General disorders | Non-systematic Assessment |
|
| Oral surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Left hip soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation and diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bone infection (Osteomyelitis) | Infections and infestations | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Genital edema | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Rash - upper arm | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Abdominal discomfort | General disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hair loss on fingers | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Overheating | General disorders | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Week 8 post-baseline |
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| Week 8 |
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| Week 8 post-baseline |
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