Green Vegetables and Women's Health
| Status: | Completed |
|---|---|
| Conditions: | Food Studies |
| Therapuetic Areas: | Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 40 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | November 2012 |
| End Date: | September 2015 |
Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Premenopausal Women
The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups
fruits and vegetables daily. However, at current intake levels, fruit consumption will have
to improve by more than 100% and vegetable intake by 50% to meet this recommendation.
Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes
are not considered. It is possible that improved fruit and vegetable intake will have
beneficial health effects. For example, higher intakes of fruits and vegetables, and
particularly cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.),
are associated with lower rates of many degenerative diseases, including some cancers, yet
this group of vegetables may continue to be under-consumed due to their strong flavors. A
supplement made from these vegetables (Cruciferous CompleteTM made by Standard Process Inc.
Palmyra, WI) contains a group of phytochemicals called glucosinolates that can shift
estrogen metabolism in a favorable way. One proposed biomarker of chemoprotection from
breast cancer is the urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16).
In the main study, the effects of cruciferous vegetables (broccoli or Brussels sprouts),
Cruciferous CompleteTM whole food supplements, or placebos on this ratio of urinary estrogen
metabolites in healthy premenopausal women will be compared over an eight-week period. The
investigators hypothesize that treatment with daily supplements will increase the 2:16 ratio
as compared to daily consumption of a combination of Brussels sprouts and broccoli or a
placebo, suggesting reduced breast cancer risk.
In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin,
lutein and lycopene with dietary carotenoid intake as measured by a food frequency
questionnaire and body composition will be evaluated in healthy premenopausal women.
Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues
and their concentration in human blood reflects dietary intake of carotenoid-rich foods.
Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual
status, but are inversely associated with body fatness. Thus, serum carotenoid
concentrations may serve as a functional marker for chronic disease risk associated with
excess body fat.
fruits and vegetables daily. However, at current intake levels, fruit consumption will have
to improve by more than 100% and vegetable intake by 50% to meet this recommendation.
Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes
are not considered. It is possible that improved fruit and vegetable intake will have
beneficial health effects. For example, higher intakes of fruits and vegetables, and
particularly cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.),
are associated with lower rates of many degenerative diseases, including some cancers, yet
this group of vegetables may continue to be under-consumed due to their strong flavors. A
supplement made from these vegetables (Cruciferous CompleteTM made by Standard Process Inc.
Palmyra, WI) contains a group of phytochemicals called glucosinolates that can shift
estrogen metabolism in a favorable way. One proposed biomarker of chemoprotection from
breast cancer is the urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16).
In the main study, the effects of cruciferous vegetables (broccoli or Brussels sprouts),
Cruciferous CompleteTM whole food supplements, or placebos on this ratio of urinary estrogen
metabolites in healthy premenopausal women will be compared over an eight-week period. The
investigators hypothesize that treatment with daily supplements will increase the 2:16 ratio
as compared to daily consumption of a combination of Brussels sprouts and broccoli or a
placebo, suggesting reduced breast cancer risk.
In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin,
lutein and lycopene with dietary carotenoid intake as measured by a food frequency
questionnaire and body composition will be evaluated in healthy premenopausal women.
Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues
and their concentration in human blood reflects dietary intake of carotenoid-rich foods.
Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual
status, but are inversely associated with body fatness. Thus, serum carotenoid
concentrations may serve as a functional marker for chronic disease risk associated with
excess body fat.
Inclusion Criteria:
- Premenopausal women between the ages of 40-50; premenopause is defined as regular
menstrual cycles every 23-35 days
- Willing to be randomized and compliant to the 3 study groups (whole cruciferous
vegetable intake, cruciferous supplement or placebo capsules)
- Able to give informed consent.
Exclusion Criteria:
- Urinary 2:16 > or = 3.
- Current kidney or liver disease, adrenalectomy, or oophorectomy.
- Use of tobacco products within the preceding three months, illegal use of medications
or use of illegal drugs or substances.
- Current use of antibiotics, cimetidine or black cohosh.
- Systemic administration of estrogen, or use of non-prescription hormones, tamoxifen,
or diabetes medication within the last three months.
- Women under a physician-directed diet or those with a strong dislike of Brassica
vegetables.
- Presence of cancer in the last 5 years, with the exception of fully resected basal or
squamous cell tumors.
- Participation in an investigational drug study in the last 30 days.
We found this trial at
1
site
Click here to add this to my saved trials
