Status:
COMPLETED
Effect of Fibre Supplementation on Mixed-meal Challenge Response
Lead Sponsor:
Centre for Human Drug Research, Netherlands
Collaborating Sponsors:
Nederlandse Organisatie voor Toegepast Natuurwetenschappelijk Onderzoek (TNO)
Conditions:
Health Status
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
Improving healthy physiological processes through nutritional intervention, as opposed to restoring physiology after disease occurrence, is an important new avenue for the reduction of disease burden ...
Detailed Description
The gut microbiome has been extensively implicated as an organ involved in various physiological processes such as nutrient and drug metabolism, microbial protection and immunomodulation. The gut micr...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study-mandated procedure.
- Healthy male or female subjects, between 45 and 70 years of age, inclusive.
- Female subjects must be of non-childbearing potential (postmenopausal for at least 12 months prior to screening or documented surgically sterile).
- BMI 25-30 kg/m2, inclusive
- Fibre intake below recommended limits as assessed by dietary fibre intake short food frequency questionnaire (DFI-FFQ) (16).
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Exclusion
- 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 relevance.
- 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.
- Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- 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 screening.
- Abnormal findings in the resting ECG at screening defined as:
- QTcF\> 450 for males or QTcF\>470 for females or QTcF \< 300 ms;
- Personal or family history of congenital long QT syndrome or sudden death;
- Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or history of cardiac pacemaker.
- Use of antibiotics, antacids, laxatives, statins, anti-diarrheal, immunomodulatory or antidiabetic medication \<3 months before start of study.
- 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.
- Vegan, macrobiotic, slimming or medically prescribed diet up to 3 months prior to the first administration.
- History of food allergies or intolerances or any confirmed significant allergic reactions (urticarial or anaphylaxis) against any drug or multiple documented drug allergies.
- Participation in an investigational drug or device study within 3 months prior to first dosing.
- 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.
- Active smoker up to 15 years prior to the screening visit.
- 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.
Key Trial Info
Start Date :
December 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04829396
Start Date
December 23 2019
End Date
July 4 2021
Last Update
August 3 2021
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands, 2333CL