Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women (ISOII)

Wageningen University

Status: Completed

Conditions: Postmenopause

Treatments: Dietary Supplement: High genistein supplement; Dietary Supplement: High daidzein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01556737

ISO II study (Other Identifier)

NL37475.081.11

Details and patient eligibility

About

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.

Full 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).

Enrollment: 72 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

72 participants in 2 patient groups, including a placebo group

Supplement

Experimental group

Treatment:

Dietary Supplement: High daidzein supplement

Dietary Supplement: High genistein supplement

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: High daidzein supplement

Dietary Supplement: High genistein supplement