Oxidative Stress and Nutritional Supplementation Intervention Study
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 09/30/2018 |
Pirmasis pateikimas: | 11/01/2010 |
Numatytas registravimas pateiktas: | 11/02/2010 |
Pirmas paskelbtas: | 11/03/2010 |
Paskutinis atnaujinimas pateiktas: | 10/22/2018 |
Paskutinis atnaujinimas paskelbtas: | 10/24/2018 |
Faktinė studijų pradžios data: | 09/30/2010 |
Numatoma pirminio užbaigimo data: | 06/30/2013 |
Numatoma studijų užbaigimo data: | 06/30/2013 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: secoisolariciresinol diglucoside
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Active Comparator: secoisolariciresinol diglucoside Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care. | |
Placebo Comparator: Placebo An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care. |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 60 Years Į 60 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - adults residing in a long term care facility - resident for a minimum of four weeks prior to entry - able to comply with study protocol - able to follow simple instructions - able to give informed consent or has a legally acceptable representative who is able to provide consent Exclusion Criteria: - Age below 60 or above 80 years. - Individuals at risk of hypotension or with symptomatic hypotension. - Fasting hypoglycemia. - Unstable diabetes - Diabetics taking insulin - Current cancer or diagnosed with cancer in the past 2 years. - Women with an immediate family history or personal history of breast cancer or ovarian cancer - Significant liver disorder - Significant gastrointestinal disorder including inflammatory bowel disease but not constipation - Significant kidney disorder - Unstable or severe cardiac disease, recent MI or stroke either in past 6 months or significantly (i.e., severely) affecting physical mobility. - Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder. - Migraine with aura within the last year (as this is a risk factor for stroke). - Current diagnosis of a bleeding condition, or at risk of bleeding. - Significant immunocompromise. - Other unstable conditions. - Current use of hormone replacement therapy except thyroid medication - Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues. - Intolerances or allergies to flax or vitamin D. - Estimated probability of longevity of less than one year based on medical opinion |
Rezultatas
Pirminės rezultatų priemonės
1. Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y) [24 weeks]
2. Effect of SDG on oxidative stress and inflammation [24 weeks]
Antrinės rezultatų priemonės
1. Effect of SDG on quality of life [24 weeks]
2. Effect of SDG supplement on blood levels of flax lignan metabolites [24 weeks]
3. To measure effects of SDG on bone resorption [24 weeks]
4. Effect of SDG on blood lipids [24 weeks]