Herbal Preparation and Glucose Homeostasis

Plain-language summary

This study examines whether a herbal supplement, compared with a placebo, affects blood sugar balance. Men and postmenopausal women aged 50-70 with a body mass index above 27 and increased fasting glucose or impaired glucose tolerance were able to take part. It was conducted as a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Wageningen University

Intervention

herbal supplement, placebo supplement

Start date

9/1/2013

Estimated completion

2/1/2014

Countries

Netherlands

Related genes

Locations

• Wageningen, Netherlands

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Males and postmenopausal females For females: menstrual cycle absent for more than 1 year
* age 50-70yrs
* BMI \>27 kg/m2
* Increased fasting glucose or an impaired glucose tolerance (two-hour glucose levels \>7.8 mmol/L on the 75-g oral glucose tolerance test or fasting glucose \>6.1mmol/L).

Exclusion Criteria:

* Systolic blood pressure \>160mmHg and diastolic blood pressure\> 100mmHg
* Tobacco smoker
* Received inoculations within 2 months of starting the study or planned during the study
* Donated or intend to donate blood from 2 months before the study till months after the study.
* Unstable body weight (weight gain or loss \>5kg in the past three months)
* Diagnosed with any long-term medical condition (e.g., diabetes, haemophilia, CVD, anemia, gastrointestinal disease, renal failure, thyroid disorders, cancer, HIV, hepatitis C)
* The use of the following medicine: medicine interfering with St Johns Worth such as, inhibitors of the immune system (ciclosporine, tacrolimus, everolimus, temsirolimus and sirolimus), coumarine type anticoagulant medicine (acenocoumarol and fenprocoumon), anti-epileptica (fenobarbital and fenytoïne), theophylline, atorvastatine, simvastatine, digoxine, kinidine, voriconazol, proton pump inhibitors (omeprazole and esomeprazole) and all anti-depressives ( incl. MAO inhibitors and SSRI's).
* Abuse of drugs/alcohol
* If the participant don't want to sign the informed consent
* If the participant don't want to be informed about unexpected findings during the screening or study
* Participation in another biomedical study
* Additional exclusion criteria for females:

Current use of contraceptives containing hormones Current use of hormone replacement therapy