The RAMP Study - Rejuvenation of the Aging Microbiota With Prebiotics
关键词
抽象
描述
The objective of this study is to define the impact of a prebiotic supplement on microbiome, immune system, and metabolic status in older adults. This study will determine the degree to which a prebiotic supplement can 1) regulate immune status and function including reducing chronic, systemic inflammation as assessed by high dimensional immune profiling, 2) alter microbiota composition and function, 3) impact the microbiota metabolites—potential normalizers of metabolic and immune dysfunction, and 4) alter metabolic markers.
日期
最后验证: | 04/30/2020 |
首次提交: | 09/16/2018 |
提交的预估入学人数: | 09/27/2018 |
首次发布: | 09/30/2018 |
上次提交的更新: | 05/06/2020 |
最近更新发布: | 05/10/2020 |
实际学习开始日期: | 03/13/2019 |
预计主要完成日期: | 11/30/2020 |
预计完成日期: | 11/30/2020 |
状况或疾病
干预/治疗
Dietary Supplement: Placebo group
Dietary Supplement: Prebiotic supplement
相
手臂组
臂 | 干预/治疗 |
---|---|
Placebo Comparator: Placebo group Placebo product | Dietary Supplement: Placebo group Placebo product |
Experimental: Prebiotic Supplement, low dose | |
Experimental: Prebiotic Supplement, high dose |
资格标准
有资格学习的年龄 | 60 Years 至 60 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 60 years old and older - Otherwise, healthy subjects willing and able to provide blood as well as stool specimens - Must be able to provide signed and dated informed consent and be willing to follow protocol Exclusion Criteria: - Body Mass Index >= 40 - LDL-C > 190 mg/dL - Systolic Blood Pressure >160 mmHg OR Diastolic Blood Pressure > 90 mmHg - Use of any of the following drugs/supplements within the last 2 months: - systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); - corticosteroids (intravenous, intramuscular, oral, nasal or inhaled) - cytokines - methotrexate or immunosuppressive cytotoxic agents - metformin - proton pump inhibitors (PPIs) - Regular use of any of the following medications: - regular dose aspirin (>81mg/day) - opiate pain medication - Use of large doses of commercial probiotics consumed (greater than or equal to 10-8 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply. - Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Examples include flu or gastroenteritis. Defer sampling until subject recover. - Chronic, clinically significant, unstable (unresolved, requiring on-going changes to medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history. Type 2 diabetes, type 1 diabetes, and dialysis will be excluded. - History of active uncontrolled gastrointestinal disorders or diseases including: - inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; - irritable bowel syndrome (IBS) (moderate-severe); - persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated). - History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision. - Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet. - Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or > 14 drinks/week. - Positive test for HIV, HBV or HCV. - Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection. - Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time. - Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products. - Any confirmed or suspected autoimmune disease. Examples include multiple sclerosis and Graves disease. - Veganism. - Dairy allergies. |
结果
主要结果指标
1. Immune status and function [Baseline and 6 weeks]
次要成果指标
1. Microbiota composition [Baseline and 6 weeks]
2. Microbiota function [Baseline and 6 weeks]
3. Weight [Baseline and 6 weeks]
4. Waist Circumference [Baseline and 6 weeks]
5. Blood pressure [Baseline and 6 weeks]
6. Total Cholesterol [Baseline and 6 weeks]
7. Triglycerides [Baseline and 6 weeks]
8. HDL-cholesterol [Baseline and 6 weeks]
9. Fasting Glucose [Baseline and 6 weeks]
10. Fasting Insulin [Baseline and 6 weeks]