Green Vegetables and Women's Health
Ключови думи
Резюме
Дати
Последна проверка: | 09/30/2015 |
Първо изпратено: | 11/01/2012 |
Очаквано записване подадено: | 11/07/2012 |
Първо публикувано: | 11/13/2012 |
Изпратена последна актуализация: | 10/04/2015 |
Последна актуализация публикувана: | 10/06/2015 |
Действителна начална дата на проучването: | 10/31/2012 |
Приблизителна дата на първично завършване: | 08/31/2015 |
Очаквана дата на завършване на проучването: | 08/31/2015 |
Състояние или заболяване
Интервенция / лечение
Other: Broccoli and Brussels Sprouts
Dietary Supplement: Cruciferous Complete
Other: Placebo
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: Broccoli and Brussels Sprouts Subjects will consume broccoli or Brussels sprouts (40g daily) for 8 weeks. | Other: Broccoli and Brussels Sprouts |
Experimental: Cruciferous Complete Subjects will take Cruciferous CompleteTM supplements (2 capsules, 3 times daily) for 8 weeks. | Dietary Supplement: Cruciferous Complete |
Placebo Comparator: Placebo Subjects will take placebo capsules (2 capsules, 3 times daily) for 8 weeks. | Other: Placebo |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 40 Years Да се 40 Years |
Полове, допустими за проучване | Female |
Приема здрави доброволци | Да |
Критерии | 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. |
Резултат
Първични изходни мерки
1. Urinary 2:16 ratio [8 weeks]
Вторични изходни мерки
1. Urinary 4OHE1 and 4OHE2 [8 weeks]
Други изходни мерки
1. Body composition [8 weeks]
2. Stability of urinary 2:16 ratio. [8 weeks]
3. Sub-study: Serum carotenoids and dietary intake [One blood draw on one day]
4. Sub-study: Serum carotenoids and body composition [One blood draw on one day]
5. Dietary Intake [8 weeks]