Pectin, Aging and Intestinal Barrier Function

Healthy Elderly Clinical Trial

Official title:

The Effects of Pectin on Aging-related Changes in Intestinal Barrier Function, Immune Function and Microbial Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376270
• Other study ID #: 143055
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2015
• Last updated: July 14, 2016
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Elderly
• Healthy Young Adults

Intervention

Dietary Supplement:
• Pectin
This group will receive 7.5 grams of pectin supplements twice daily for four weeks.
• Maltodextrin
This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sugar recovery in urine, as indicator of intestinal permeability		Change from Baseline to after 4 weeks of intervention	No
Secondary	Tight junction structure and proteins in colonic biopsies, as indicator of intestinal barrier function		After 4 weeks of intervention	No
Secondary	Ussing chamber experiments in colonic biopsies, as indicator of intestinal barrier function		After 4 weeks of intervention	No
Secondary	Histology in colonic biopsies, as indicator of intestinal barrier function		After 4 weeks of intervention	No
Secondary	MiR-29a in colonic biopsies, as indicator of intestinal barrier function		After 4 weeks of intervention	No
Secondary	Zonulin in blood plasma, as indicator of intestinal barrier function		Change from Baseline to after 4 weeks of intervention	No
Secondary	Immune infiltration cells in colonic biopsies, as indicator of immune system performance		After 4 weeks of intervention	No
Secondary	T-cells and Natural Killer cells in blood plasma, as indicator of immune system performance		Change from Baseline to after 4 weeks of intervention	No
Secondary	Cytokines Interleukin-10 and Interleukin-12 in blood plasma, as indicator of immune system performance		Change from Baseline to after 4 weeks of intervention	No
Secondary	C-reactive protein in blood serum, as indicator of immune system performance		Change from Baseline to after 4 weeks of intervention	No
Secondary	Secretory Immunoglobulin A in blood serum, as indicator of immune system performance		Change from Baseline to after 4 weeks of intervention	No
Secondary	Microbial composition in luminal content and feces		Change from Baseline to after 4 weeks of intervention	No
Secondary	Short-chain fatty acids in luminal content and feces, as indicator of microbial function		Change from Baseline to after 4 weeks of intervention	No
Secondary	Volatile organic compounds in exhaled air, as indicator for metabolite production		Change from Baseline to after 4 weeks of intervention	No
Secondary	Symptom diary questionnaire, as indicator of digestive parameters		Change from three days prior to the supplementation period to three days during the last week of the supplementation period	No
Secondary	Stool frequency and consistency questionnaire, as indicator of digestive parameters		Change from Baseline to after 4 weeks of intervention	No
Secondary	Gastrointestinal Symptom Rating Scale questionnaire, as indicator of digestive parameters		Change from Baseline to after 4 weeks of intervention	No