Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01556737
Other study ID # NL37475.081.11
Secondary ID ISO II study
Status Completed
Phase N/A
First received January 9, 2012
Last updated October 30, 2012
Start date November 2011
Est. completion date September 2012

Study information

Verified date October 2012
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

Alleged benefits experienced after the consumption of soy in Asian countries have been attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are believed to relieve menopausal symptoms and are therefore often consumed in supplement form in Western countries. These supplements contain relatively high amounts of isoflavones and are on the market in different compositions. The question is whether supplements with different compositions exert similar effects or whether the effects differ substantially.


Description:

Intervention study with two substudies; each substudy is a double blind placebo controlled crossover intervention study. The first substudy has two groups: 'high daidzein' supplement versus placebo (n=18) and vice versa (n=18); the second substudy also has two groups 'high genistein' versus placebo (n=18) and vice versa (n=18).


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria:

- Female

- 50-70 years

- menstrual cycle absent for more than 1 year

Exclusion Criteria:

- current use of contraceptives containing hormones

- current use of hormone replacement therapy

- regular soy product use (more than once a week)

- regular isoflavone supplement use (more than once a week)

- current use of medication containing sexhormones or sexhormone-triggering compounds

- current use of anti-inflammatory medicines

- use of antibiotics in the past 3 months

- severe heart disease

- diabetes

- thyroid disorders --> use of medicines for thyroid disorders

- removed thyroid gland

- complete ovarectomy

- prior diagnosis of cancer

- alcohol and drug abuse

- current smoker

- BMI >35 kg/m2

- allergy to soy (products)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High daidzein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones
High genistein supplement
8 weeks exposure to the supplement, daily 100 mg of isoflavones

Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gene-expression in PBMCs after placebo vs after treatment measured by microarrays after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo No
Secondary Isoflavone levels in plasma after placebo vs after treatment measured by HPLC before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo No
Secondary Gene - expression in adipose tissue after placebo vs after treatment measured by QPCR after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo No
Secondary Isoflavone levels in adipose tissue levels after placebo vs levels after treatment measured by HPLC after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo No
See also
  Status Clinical Trial Phase
Completed NCT05448079 - The Effect of Sexual Counseling Given According to the PLISSIT Model on FSFI, MAS and SQOL-F of Postmenopausal Women N/A
Completed NCT00745173 - Study Evaluating Premarin and Bazedoxifene Potential Interaction Phase 1
Completed NCT00550433 - Study Evaluating Bazedoxifene/CE in Postmenopausal Women Phase 1
Completed NCT00913926 - Effects of Wellnara on Climacteric Symptoms N/A
Completed NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00515593 - PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE) N/A
Completed NCT00484107 - Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women Phase 4
Completed NCT00185328 - Efficacy and Tolerability of Angeliq in Thai Women Phase 4
Completed NCT00023543 - Reduction of Triglycerides in Women on Hormone Replacement Therapy Phase 2
Completed NCT00152282 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women Phase 2
Completed NCT00006407 - Sex Steroid Hormones and Risk of CHD in Women N/A
Completed NCT00006539 - Thrombotic, Inflammatory & Gene Markers of CVD in Women N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Completed NCT00001752 - Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women Phase 2
Completed NCT00005515 - Mutations, Hormone Therapy (HRT) and Venous Thromboembolism N/A
Completed NCT00000481 - Women's Health Trial: Feasibility Study in Minority Populations Phase 3
Completed NCT00000466 - Postmenopausal Estrogen/Progestin Interventions (PEPI) Phase 3
Completed NCT00543634 - Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women Phase 1
Completed NCT06115577 - Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes
Completed NCT00455741 - Postmenopausal Women Estrogen and Progesterone Infusion Phase 1/Phase 2