Meta AnalysisID 7159
大豆异黄酮对雌激素相关中间结局的影响：随机对照试验的系统评价和Meta分析
CRD42023439239
What are the effects of soy isoflavones on estrogen-related intermediate outcomes in post-menopausal women of all health backgrounds, compared to a suitable non-isoflavone containing control in randomized controlled tria
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Record Fields
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- Meta Analysis Id
- 7159
- Evidence Id
- 15717
- Core Evidence Id
- 15717
- Source Meta Analysis Id
- 7142
- Herb2 Meta Analysis Id
- HBMA007142
- Crd Id
- CRD42023439239
- Title
- The effect of soy isoflavones on estrogen-related intermediate outcomes: A systematic review and meta-analysis of randomized controlled trials.
- Review Question
- What are the effects of soy isoflavones on estrogen-related intermediate outcomes in post-menopausal women of all health backgrounds, compared to a suitable non-isoflavone containing control in randomized controlled trials of at least 3 months in duration?
- Study Type Included
- Inclusion criteria: Randomized controlled trials in post-menopausal females with intervention periods ≥ 3 months Exclusion criteria: Observational studies, case studies, comments, editorials, reviews, randomized controlled trials conducted in children, males, non-menopausal females, or pregnant females, randomized controlled trials with intervention periods of less than 3 months
- Condition Being Studied
- Soy protein is a recommended protein source in dietary guidelines and major cardiovascular clinical practice guidelines and has approved health claims for its cholesterol lowering properties and ability to reduce risk of coronary artery disease. On the other hand, the isoflavones in soybeans, which are classified as phytoestrogens, are the subject of controversy. Although isoflavones are proposed to exert several health benefits, such as reducing risk of osteoporosis and alleviating menopausal symptoms, there is concern that among others, these soybean constituents increase breast cancer risk and feminize men. However, despite their classification as phytoestrogens, evidence indicates isoflavones differ from the hormone estrogen clinically and at the molecular level. There is clearly a need to better characterize isoflavones related to their proposed estrogenic properties. To address this need, we propose to conduct a systematic review and meta-analysis of clinical studies involving postmenopausal women that evaluated the effect of soy isoflavone exposure on outcomes affected by the hormone estrogen: follicle stimulating hormone levels, endometrial thickness and vaginal maturation.
- Participant
- Inclusion criteria: Post-menopausal females Exclusion criteria: Non-menopausal females, pregnant and breastfeeding females, males, individuals <18 years old
- Animal
- Human Disease Modelled
- Intervention
- Inclusion criteria: dietary interventions containing isoflavones from soy Exclusion criteria: dietary interventions containing no isoflavones or isoflavones from a non-soy food source
- Comparator Control
- Inclusion criteria: suitable non-soy, non-isoflavone containing control Exclusion criteria: soy isoflavone-containing control
- Main Outcome
- The primary outcomes will be the mean pairwise differences in change-from-baseline (or alternatively, end differences) between the intervention arm providing isoflavones from soy and the comparator/control arm in each trial comparison in vaginal maturation index, endometrial thickness, levels of follicle-stimulating hormone (FSH) and levels of estradiol. Measures of effect Mean pairwise differences in change-from-baseline (or alternatively, end differences) between the intervention arm providing the soy isoflavones and the comparator/control arm in each trial comparison (significance at P<0.05)
- Outcome Measure
- Additional Outcome
- Study Method
- Epidemiologic, Intervention, Meta-analysis, Systematic review
- Keyword
- Estrogens; Female; Humans; Isoflavones; Menopause; Randomized Controlled Trials as Topic
- Contact
- Laura Chiavaroli [email protected]
- Organisational Affiliation
- University of Toronto
- Funding Source
- Soy Nutrition Institute, Undergraduate Research Opportunity Program
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Canada
- Review Stage
- Review Ongoing
- First Submission Date
- 2023-06-27
- Registration Date
- 2023-07-07
- Anticipated Start Date
- 2023-07-03
- Anticipated Completion Date
- 2023-10-09
- Title Cn
- 大豆异黄酮对雌激素相关中间结局的影响：随机对照试验的系统评价和Meta分析
- Title En
- The effect of soy isoflavones on estrogen-related intermediate outcomes: A systematic review and meta-analysis of randomized controlled trials.
- Bilingual Status
- complete