Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women
Ключови думи
Резюме
Описание
PRIMARY OBJECTIVES:
I. Evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1&-E2, 4-MeOH-E1&-E2) thought to be involved in the development of breast cancer.
SECONDARY OBJECTIVES:
II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels.
III. Describe adherence to the flaxseed intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1: Participants take 2 tablespoons of ground flaxseed daily for approximately 50 days.
ARM 2: Participants maintain their usual diet for approximately 50 days.
All participants will complete a questionnaire and have their blood drawn at the beginning of the study (Day 0) and at the end of the study period (approximately Day 50).
Дати
| Последна проверка: | 12/31/2017 |
| Първо изпратено: | 07/12/2015 |
| Очаквано записване подадено: | 07/14/2015 |
| Първо публикувано: | 07/16/2015 |
| Изпратена последна актуализация: | 01/09/2018 |
| Последна актуализация публикувана: | 01/11/2018 |
| Действителна начална дата на проучването: | 08/31/2015 |
| Приблизителна дата на първично завършване: | 05/31/2016 |
| Очаквана дата на завършване на проучването: | 12/31/2017 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Flaxseed (ground)
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Flaxseed (ground) | Dietary Supplement: Flaxseed (ground) 2 tablespoons of ground flaxseed taken daily for approximately 50 days. |
| No Intervention: Usual diet |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 57 Years Да се 57 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: 1. Women residing in Toronto aged 57-64 years old, and post-menopausal. Exclusion Criteria: 1. Consumers of flaxseed and soy (including supplements) in the past 6 months. 2. Consumers of sesame oil and sesame seeds in the past 6 months. 3. Women who took antibiotics orally in the past 6 months. 4. Women who took hormone replacement therapy or corticosteroids in the past month. 5. Non-English speaking. 6. Current chronic illnesses such as bowel disease (e.g. IBS - irritable bowel syndrome, or IBD - inflammatory bowel disease, such as Crohn's or ulcerative colitis), diabetes, heart disease (e.g. high cholesterol or high blood pressure and on medication for it), cancer, or another chronic illness. 7. Women who are currently taking blood thinners, such as Warfarin. |
Резултат
Първични изходни мерки
1. Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period) [Day 0 and ~Day 50]
Вторични изходни мерки
1. Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period) [Day 0 and ~Day 50]
