Supplementation Trial on Arginine With Metabolic Profiling
Ключови думи
Резюме
Описание
A double - blind randomized, crossover design trial examining arginine vs. placebo beverage treatments will be performed. The primary objective is to determine the effects of arginine assessed by standard laboratory assays and metabolomics. To accomplish the objective standardized meals will be provided for 2 days preceding treatment for dietary consistency. Participants will arrive at the center following a 10-12 hr fast. Blood samples will be collected at baseline (fasting), 1.5 hrs, 3.0 hrs, 6.0 hrs, and 24 hrs post treatment. Plasma prolactin, growth hormone, amino acids, glucose, insulin, triacylglycerols, thyroid hormones (TSH, T3, and T4), sex hormone binding globulin (SHBH), testosterone, cortisol, DHEA, and citrulline will be measured. Metabolomics will be measured at 3 time points for each treatment. Peripheral arterial tonometry (PAT) will also be performed at ~2 hrs following treatment to examine endothelial function in response to nitrous oxide release. In addition, psychological status including fatigue will be assessed using a standardized mood questionnaire (POMS).
Дати
| Последна проверка: | 07/31/2019 |
| Първо изпратено: | 01/10/2018 |
| Очаквано записване подадено: | 01/16/2018 |
| Първо публикувано: | 01/23/2018 |
| Изпратена последна актуализация: | 08/25/2019 |
| Последна актуализация публикувана: | 08/27/2019 |
| Действителна начална дата на проучването: | 02/07/2018 |
| Приблизителна дата на първично завършване: | 07/07/2019 |
| Очаквана дата на завършване на проучването: | 12/14/2019 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Arginine
Dietary Supplement: Placebo
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Arginine Arginine drink provided 1 time. There is about 10 g of arginine in the product. | Dietary Supplement: Arginine 10 g of arginine in a formulated drink |
| Placebo Comparator: Placebo Placebo drink provided 1 time. | Dietary Supplement: Placebo formulated drink |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - BMI 18.5 - 25 kg/m2. - Must be physically active (exercise at least 2 days/week). - Willing to refrain from alcohol and supplements for the duration of the study. - Willing to refrain from supplement ingestion, nuts, watermelon, and cracklins (fatback) for the 2 weeks prior to the initial treatment diet through the duration of the study. Exclusion Criteria: - HIV or AIDS - Uncontrolled CVD/arrhythmia - Type I or type II diabetes - Pregnancy (or breastfeeding) - Diagnosed eating disorder - Non-normal sleeping patterns - Chronic neurological condition - Altered metabolism including growth hormone disorders - Use of nicotine or tobacco products - Heavy caffeine use (≥ 350 mg caffeine/d) - Whole blood donation within previous eight weeks - Protein supplementation - Protein wasting disease. - Exclusionary medications include diuretics, beta-blockers, weight loss medications or diet pills, anti-inflammatory drugs (corticosteroid/ anabolic steroid/NSAID), antipsychotic medication or other medication that may affect fluid balance, metabolism, or body weight. - Prisoners and adults who are unable to consent will be excluded from the study. - Lastly any other medical, psychiatric, or behavioral factors in the judgement of the Principle Investigator that may interfere with study participation or the ability to follow the protocol. |
Резултат
Първични изходни мерки
1. Growth Hormone [baseline (fasting), 1.5, 3.0, 6.0, and 24.0 hrs]
