Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
Ключови думи
Резюме
Дати
| Последна проверка: | 11/30/2016 |
| Първо изпратено: | 07/02/2013 |
| Очаквано записване подадено: | 07/08/2013 |
| Първо публикувано: | 07/09/2013 |
| Изпратена последна актуализация: | 12/07/2016 |
| Последна актуализация публикувана: | 02/01/2017 |
| Дата на първите подадени резултати: | 06/01/2016 |
| Дата на първите подадени резултати от QC: | 06/01/2016 |
| Дата на първите публикувани резултати: | 07/12/2016 |
| Действителна начална дата на проучването: | 06/30/2014 |
| Приблизителна дата на първично завършване: | 11/30/2014 |
| Очаквана дата на завършване на проучването: | 11/30/2014 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: LOVAZA
Drug: GnRH
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Obese Women Women with a BMI of greater than or equal to 30 kg/m2 underwent all study interventions, including taking 5 g daily of LOVAZA. Women underwent 8 hours of frequent blood sampling every 10 minutes both at baseline and after LOVAZA supplementation. Each frequent blood sampling included IV administration of GnRH at 6 hours. | |
| Active Comparator: Normal Weight Women with a BMI of between 18-25 kg/m2 underwent all study interventions, including taking 5 g daily of LOVAZA for one cycle. Women underwent 8 hours of frequent blood sampling every 10 minutes both at baseline and after LOVAZA supplementation. Each frequent blood sampling included IV administration of GnRH at 6 hours. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: 1. Age 18-42 at study entry 2. Regular menstrual cycles every 25-40 days 3. BMI at least 30 kg/m2 (obese) or between 18.5 and 25 kg/m2 (normal) 4. Good general health 5. Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening, baseline hemoglobin >11 gm/dl. Exclusion Criteria: 1. Diagnosis of polycystic ovary syndrome (by ultrasound or hyperandrogenic symptoms) 2. Fish or seafood allergy or hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of the formulation 3. Coagulopathy or receiving therapeutic anticoagulation (due to potential for interaction with omega-3 FA) 4. History of chronic disease affecting hormone production, metabolism or clearance (including diabetes mellitus) 5. Abnormal renal or liver function at screening 6. Current use of thiazolidinediones or metformin (known to interact with reproductive hormones) 7. Use of hormones affecting hypothalamic output (HPO) axis (such as hormonal contraceptives) within three months of entry 8. Strenuous exercise (>4 hours of intense physical activity per week) 9. Pregnancy 10. Breast-feeding 11. Current active attempts to conceive 12. History of significant recent weight loss or gain |
Резултат
Първични изходни мерки
1. Change in the Average LH Pulse Amplitude [10 minute intervals during 8 hour blood sampling studies. Subjects will undergo two menstrual cycles of study, one prior to dietary supplementation and one after supplementation.]
