NL-OMON55244已完成不适用
A randomized, double-blind, placebo-controlled crossover study to assess the effect of 12-week fibre supplementation on mixed-meal challenge response in adults - Effect of fibre supplementation on mixed-meal challenge response.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed informed consent prior to any study-mandated procedure.
- •2. Healthy male or female subjects, between 45 and 70 years of age, inclusive.
- •3. Female subjects must be of non-childbearing potential (postmenopausal for at
- •least 12 months prior to screening or documented surgically sterile).
- •4. BMI 25-30 kg/m2
- •5. Fibre intake below recommended limits as assessed by dietary fibre intake
- •short food frequency questionnaire (DFI-FFQ).
- •6. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
排除标准
- •1. Evidence of any active or chronic disease or condition that could interfere
- •with, or for which the treatment of might interfere with, the conduct of the
- •study, or that would pose an unacceptable risk to the subject in the opinion of
- •the investigator (following a detailed medical history, physical examination,
- •vital signs (systolic and diastolic blood pressure, pulse rate, body
- •temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the
- •normal range may be accepted, if judged by the Investigator to have no clinical
- •2. Chronic diseases that can affect study parameters, including but not limited
- •to metabolic syndrome, chronic obstructive pulmonary disease, diabetes
- •mellitus, auto-immune disease, cardiovascular disease, cerebrovascular disease,
- •gastrointestinal disease or history of abdominal surgery with removal of (part
- •of) small or large intestine, or any known condition that can interfere with
- •treatment compliance such as psychiatric disease or drug dependence.
- •3. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
- •or human immunodeficiency virus antibody (HIV Ab) at screening.
- •4. Systolic blood pressure (SBP) greater than 180 or less than 90 mm Hg, and
- •diastolic blood pressure (DBP) greater than 120 or less than 50 mm Hg at
- •5. Abnormal findings in the resting ECG at screening defined as:
- •a. QTcF> 450 for males or QTcF>470 for females or QTcF < 300 ms;
- •b. Personal or family history of congenital long QT syndrome or sudden death;
- •c. Evidence of atrial fibrillation, atrial flutter, complete branch block,
- •Wolf-Parkinson-White Syndrome, or history of cardiac pacemaker.
- •6. Use of antibiotics, antacids, laxatives, statins, anti-diarrheal,
- •immunomodulatory or antidiabetic medication <3 months before start of study.
- •7. Use of any medication or vitamin, mineral, herbal, and dietary supplements
- •within 7 days of study product administration, or less than 5 half-lives
- •(whichever is longer). Exceptions will only be made if the rationale is clearly
- •documented by the investigator.
- •8. Vegan, macrobiotic, slimming or medically prescribed diet up to 3 months
- •prior to the first administration.
- •9. History of food allergies or intolerances or any confirmed significant
- •allergic reactions (urticarial or anaphylaxis) against any drug or multiple
- •documented drug allergies.
- •10. Participation in an investigational drug or device study within 3 months
- •prior to first dosing.
- •11. History of abuse of addictive substances (alcohol, illegal substances) or
- •current use of more than 21 units alcohol per week, drug abuse, or regular user
- •of sedatives, hypnotics, tranquillisers, or any other addictive agent, or
- •positive test for drugs of abuse at screening or pre-dose.
- •12. Active smoker up to 15 years prior to the screening visit.
- •13. Loss or donation of blood over 500 mL within three months (males) or four
- •months (females) prior to screening or intention to donate blood or blood
- •products during the study.
研究者
相似试验
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled crossover study to assess the efficacy's reproducibility of a combination of Pseudoephedrine and Cetirizine on symptom scores and rhinomanometry in patients with allergic rhinitis following pollen exposure in the Fraunhofer Environmental Challenge Chamber (ECC) in- and outside the grass pollen seasosubjects with seasonal allergic rhinitisEUCTR2007-001587-70-DEFraunhofer Gesellschaft
已完成
不适用
A randomized, double-blind, placebo-controlled cross-over study of epicutaneous immunotherapy for food allergy.Food allergyJPRN-UMIN000033049Department of Pediatrics, Hachioji Hospital, Faculty of Medicine, Tokai University13
尚未招募
Unknown
A clinical trial on the effect of lactulose on mineral absorption.JPRN-UMIN000052813KSO Corporation100
进行中（未招募）
1 期
A phase IIb study of OligoG in subjects with cystic fibrosisCystic FibrosisEUCTR2014-000844-13-SEAlgipharma AS76
进行中（未招募）
1 期
A phase IIb study of OligoG in subjects with cystic fibrosisCystic FibrosisEUCTR2014-000844-13-DKAlgipharma AS76