Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients
Кључне речи
Апстрактан
Датуми
| Последња верификација: | 12/31/2018 |
| Фирст Субмиттед: | 01/29/2019 |
| Предвиђена пријава послата: | 01/29/2019 |
| Прво објављено: | 01/31/2019 |
| Послато последње ажурирање: | 01/29/2019 |
| Последње ажурирање објављено: | 01/31/2019 |
| Стварни датум почетка студије: | 07/31/2017 |
| Процењени датум примарног завршетка: | 11/30/2018 |
| Предвиђени датум завршетка студије: | 11/30/2018 |
Стање или болест
Интервенција / лечење
Dietary Supplement: Arm I (glucosamine sulfate/chondroitin sulfate tablet)
Other: Arm II (placebo)
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Experimental: Arm I (glucosamine sulfate/chondroitin sulfate tablet) Patients receive glucosamine sulfate/chondroitin sulfate tablet PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm II. | Dietary Supplement: Arm I (glucosamine sulfate/chondroitin sulfate tablet) Given PO |
| Placebo Comparator: Arm II (placebo) Patients receive placebo PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm I. | Other: Arm II (placebo) Given PO |
Критеријуми
| Узраст подобан за студирање | 20 Years До 20 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: -Individuals from the Greater Seattle area who are overweight (body mass index [BMI] of 25-32.5 kg/m^2) Exclusion Criteria: - Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases) - Pregnancy or lactation - Currently on a weight-loss diet - BMI (body mass index) < 25 or > 32.5 kg/m^2 - Alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits) - Current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (IUD)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), or use of aspirin or NSAIDs more than 2 days per week - Abnormal renal, liver or metabolic test - Inability to swallow pills - Known allergy to shellfish - Not willing to take pills made from shellfish or animal sources - Intention to relocate out of study area within next 2 months - Any antibiotic use in the past 6 months |
Исход
Примарне мере исхода
1. Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation [Up to 2 years]
2. Effects of G&C on serum C-reactive protein (CRP) [Up to 2 years]
