Prebiotic Effects of Isomalto-oligosaccharide
关键词
抽象
日期
| 最后验证: | 02/28/2017 |
| 首次提交: | 04/24/2015 |
| 提交的预估入学人数: | 05/03/2015 |
| 首次发布: | 05/04/2015 |
| 上次提交的更新: | 03/20/2017 |
| 最近更新发布: | 03/22/2017 |
| 实际学习开始日期: | 03/31/2015 |
| 预计主要完成日期: | 10/31/2015 |
| 预计完成日期: | 11/30/2016 |
状况或疾病
干预/治疗
Dietary Supplement: Isomalto-oligosaccharide
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: Placebo Ingredients that are in the placebo are: high maltose corn syrup (Satin Sweet™), water, and mannitol. Both Supplement A and Supplement B will be compared to this placebo arm. | |
| Experimental: Supplement A Ingredients that are in the supplement are: isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Supplement A and B differ by degrees of polymerization. | |
| Experimental: Supplement B Ingredients that are in the supplement are: isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Supplement A and B differ by degrees of polymerization. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Provide signed and dated informed consent form - Willing to comply with all study procedures and be available for the duration of the study - Male or female, aged 18 to 45 years of age - In good general health as evidenced by medical history - Women of reproductive potential must use highly effective contraception - Body mass index of 25 kg/m2 or higher - Weigh less than 350 lbs. Exclusion Criteria: - History of colon cancer - History of rheumatoid arthritis - Active self-reported febrile illness (may enroll after 2-week waiting period following the day that the illness/fever is resolved) - Taking TNF-alpha inhibitors, COX2 inhibitors, JAK inhibitors - History of hypothyroidism (with or without treatment) - History of inflammatory bowel disease (ulcerative colitis and Crohn's disease) - Type I or Type II diabetes - History of Parkinson's Disease, Huntington's Disease or Multiple Sclerosis - History of major depression, bipolar disorder, or schizophrenia - Pregnant or lactating women - Currently suffering from migraine headaches (at least one migraine headache in the past 30 days) - Current use of any prescription or non-prescription weight loss products - Consumption of more than 2 drinks per day of alcohol - Tobacco smoker (over ½ pack per week is excluded) - Marijuana smoker (over once per month is excluded) - Currently have an eating disorder including anorexia nervosa, bulimia, and/or obsessive compulsive disorders - Plan to start a new diet or make changes to their current diet during the study - Diagnosis of Coronary Artery Disease who have had chest pain within the past 2 months - Diagnosis of Congestive Heart Failure who have had any episodes of shortness of breath within the last 2 months - History of stroke within the past 1 year - History of ventricular tachycardia or fibrillation - History of hypertension that has been difficult to control with medication (based on medical history - e.g. requiring more than 2 medication to achieve control) - History of seizures in the last 5 years - Cancer diagnosis in the last 5 years (except non-melanoma skin cancer or in-situ cervical cancer) - History of bariatric or lapband surgery - Usual or planned consumption of more than 2 servings per week of yogurt, kombucha, kefir, or kimichi - Regular use of antibiotics - Use of antibiotics in the previous 2 weeks - Current and continued use of prebiotics or probiotics - Known allergic reactions to components of the study supplement or placebo |
结果
主要结果指标
1. Change in gut bacterial DNA from baseline, extracted from fecal sample [4 weeks]
2. Change in gut bacterial DNA from baseline, extracted from fecal sample [8 Weeks]
次要成果指标
1. Body weight change from baseline [Week 4]
2. Change from baseline in self-reported digestive health measured by questionnaire [Week 4]
3. Change from baseline in self-reported digestive health measured by questionnaire [Week 8]
4. Body weight change from baseline [Week 8]
