Obesity Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are a woman who has gone through menopause (no periods for 12+ months, or you've had both ovaries or your uterus removed, confirmed by hormone levels if needed)
• You are 21 years of age or older
• You have a body mass index (BMI) of 30 or higher (or 25 or higher if you are of Asian heritage) — this is a measure of body weight relative to height
• You are considered at higher-than-average risk of developing breast cancer, which may be because of one or more of the following:
  • You carry a known gene mutation linked to hereditary breast cancer (such as BRCA1, BRCA2, or p53)
  • One or more close family members (parent, sibling, or child) has had breast cancer, with at least one of them diagnosed before age 60
  • Two or more second-degree relatives (such as grandparents, aunts, or cousins) have had breast cancer, with at least one diagnosed before age 50
  • A breast biopsy in the last 10 years showed certain pre-cancerous or early abnormal cells (confirm with trial site)
  • A standard breast cancer risk scoring tool called the Gail Risk Assessment gave you a 5-year risk score of 1.7% or higher
  • You were previously diagnosed with an early-stage breast cancer (Stage 1 or 2) at least 5 years ago, and have not been on anti-estrogen therapy for more than six months (confirm with trial site)
• You had a mammogram within the last 12 months that was not considered suspicious for cancer; if it showed something unclear, a biopsy came back negative
• Your blood test results for kidney function, liver function, and blood counts are within acceptable ranges (confirm specific values with trial site)
• You are willing and able to have about 8–10 teaspoons of blood drawn at the start of the study and again at 3 months
• You are able to swallow pills
• You are generally healthy and able to carry out everyday activities with no more than minor limitations (confirm with trial site)
• Any previous cancer treatments or breast cancer prevention therapies were completed at least 6 months before joining the study
• Any previous use of mushroom-based supplements was stopped at least 3 months before joining the study
• You are able to understand and sign a written consent form after being fully informed about the study

Who may not be able to join:

• You have been diagnosed with an active cancer in the past 5 years (except certain skin cancers or early cervical abnormalities), or you are currently receiving treatment for a prior cancer
• You are currently receiving chemotherapy, radiation, or any other cancer treatment
• You have a history of bleeding problems, or you currently take blood thinners such as Coumadin (warfarin)
• You have used hormone-related medications — such as hormone replacement therapy (HRT), SERMs, aromatase inhibitors, or certain hormone-regulating drugs — within the past 3 months (note: local vaginal hormone creams are allowed)
• You are currently taking medications that suppress the immune system
• You have an uncontrolled ongoing illness, such as an active infection, serious heart condition, uncontrolled high blood pressure, or a mental health situation that could make it difficult to participate safely
• You have regularly used any herbal or dietary supplement containing mushrooms in the 3 months before joining the study
• You are currently participating in another clinical research trial involving an experimental treatment
• You are premenopausal (still having regular periods)
• You have a known allergy or sensitivity to ingredients similar to those in the study supplement (confirm with trial site)
• You regularly take full-dose aspirin (325 mg or more per day) or anti-inflammatory medications such as ibuprofen or naproxen on a regular basis
• The trial doctor has any other safety concern about your participation in the study

Important: Always verify eligibility with the trial site directly before applying.