Health status Health status
Conditions
Interventions
Investigational fibre mixture (active treatment)
The study product is a fibre mixture consisting of a mix of 10 g of Acacia Gum
(AG) and 3 g of carrot fibre (KaroPRO) taken p.o. o.d. in powder form f
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 relevance. 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 screening. 5. Abnormal findings in the resting ECG at screening defined as: a. QTcF> 450 for males or QTcF>470 for females or QTcF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints * Microbiome changes measured using 16S rRNA sequencing at baseline and at time points as defined in table 1 and 2. * Response to challenge of metabolic and inflammatory biomarkers including but not limited to non-esterified fatty acids (NEFAs), glucose, insulin, triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, interleukin-6, -8 and -10, tumour necrosis factor alpha (TNF-*), high-sensitivity C-reactive protein (hs-CRP), serum amyloid A (SAA), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyltransferase (GGT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints * Baseline and post-intervention metabolic and inflammatory biomarkers including but not limited to NEFAs, glucose, insulin, TG, HDL, LDL, total cholesterol, interleukin-6, -8 and -10, TNF-*, hs-CRP, SAA, ALT, AST and GGT. * In vitro culturing of stool through the TNO I-screen platform and faecal SCFA content at baseline and before the second treatment period. | — |
Countries
Netherlands
Outcome results
None listed