Clinical trial NCT02376270: Pectin, Aging and Intestinal Barrier Function
Official title: The Effects of Pectin on Aging-related Changes in Intestinal Barrier Function, Immune Function and Microbial Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Young Adults
Healthy Elderly
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The population is aging worldwide, which requires more attention to health needs and leads to a dramatic increase in health care costs. Prevention or delay of onset of disorders associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have beneficial effects on gut health parameters, i.e. intestinal barrier function, immune function and microbial composition. As intestinal barrier function may be compromised in the elderly we will investigate whether the effects of pectin on selected parameters of gut health differ between young vs. older individuals. The primary objective of this study is to investigate the effects of aging on pectin-induced changes in intestinal permeability. Furthermore, this study has seven secondary objectives. This study conforms to a randomized, double-blind and placebo-controlled design including two parallel arms.The study population consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30 kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A second group will receive 7.5 grams of placebo supplements twice daily for four weeks. Before and after the supplementation period, several measurements will take place. The main study parameter is the change in urinary sugar excretion ratio before and after the intervention period.


Eligibility criteria: Inclusion Criteria:

* Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined.
* Age between 18 - 40 years and 65 - 75 years.
* Body Mass Index (BMI) between 20 and 30 kg/m2. Normal BMI has been chosen because obesity is associated with an altered microbial composition and increased intestinal permeability.

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
* Use of proton-pump inhibitors, nonsteroidal anti-inflammatory drugs and/or vitamin supplementation, within 14 days prior to testing. Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used.
* Administration of probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 90 days prior to the study
* Use of antibiotics in the 90 days prior to the study.
* Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator).
* Pregnancy, lactation.
* Excessive alcohol consumption (\>20 alcoholic consumptions per week).
* Smoking.
* Blood donation within 3 months before or after the study period.
* Self-admitted human immunodeficiency virus-positive state.
* History of side effects towards intake of prebiotic supplements.

Primary outcomes:
measure: Sugar recovery in urine, as indicator of intestinal permeability
timeFrame: Change from Baseline to after 4 weeks of intervention
Secondary outcomes:
measure: Tight junction structure and proteins in colonic biopsies, as indicator of intestinal barrier function
timeFrame: After 4 weeks of intervention
measure: Ussing chamber experiments in colonic biopsies, as indicator of intestinal barrier function
timeFrame: After 4 weeks of intervention
measure: Histology in colonic biopsies, as indicator of intestinal barrier function
timeFrame: After 4 weeks of intervention
measure: MiR-29a in colonic biopsies, as indicator of intestinal barrier function
timeFrame: After 4 weeks of intervention
measure: Zonulin in blood plasma, as indicator of intestinal barrier function
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: Immune infiltration cells in colonic biopsies, as indicator of immune system performance
timeFrame: After 4 weeks of intervention
measure: T-cells and Natural Killer cells in blood plasma, as indicator of immune system performance
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: Cytokines Interleukin-10 and Interleukin-12 in blood plasma, as indicator of immune system performance
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: C-reactive protein in blood serum, as indicator of immune system performance
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: Secretory Immunoglobulin A in blood serum, as indicator of immune system performance
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: Microbial composition in luminal content and feces
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: Short-chain fatty acids in luminal content and feces, as indicator of microbial function
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: Volatile organic compounds in exhaled air, as indicator for metabolite production
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: Symptom diary questionnaire, as indicator of digestive parameters
timeFrame: Change from three days prior to the supplementation period to three days during the last week of the supplementation period
measure: Stool frequency and consistency questionnaire, as indicator of digestive parameters
timeFrame: Change from Baseline to after 4 weeks of intervention
measure: Gastrointestinal Symptom Rating Scale questionnaire, as indicator of digestive parameters
timeFrame: Change from Baseline to after 4 weeks of intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Department of Internal Medicine, Division of Gastroenterology-Hepatology
name: A.A.M. Masclee, Professor
role: PRINCIPAL_INVESTIGATOR
References: