Pectin, Aging and Intestinal Barrier Function

NCT02376270 | Completed Phase 4

• 1 other identifier: 143055
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Young Adults; Healthy Elderly

Outcome Measures

Primary Outcomes (1)

• Sugar recovery in urine, as indicator of intestinal permeability

  Change from Baseline to after 4 weeks of intervention

Secondary Outcomes (16)

• Tight junction structure and proteins in colonic biopsies, as indicator of intestinal barrier function

  After 4 weeks of intervention

• Ussing chamber experiments in colonic biopsies, as indicator of intestinal barrier function

  After 4 weeks of intervention

• Histology in colonic biopsies, as indicator of intestinal barrier function

  After 4 weeks of intervention

• MiR-29a in colonic biopsies, as indicator of intestinal barrier function

  After 4 weeks of intervention

• Zonulin in blood plasma, as indicator of intestinal barrier function

  Change from Baseline to after 4 weeks of intervention

Study Arms (2)

Pectin

EXPERIMENTAL

This group will receive 7.5 grams of pectin supplements twice daily for four weeks.

Dietary Supplement: Pectin

Maltodextrin

PLACEBO COMPARATOR

This group group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.

Dietary Supplement: Maltodextrin

Interventions

Pectin DIETARY_SUPPLEMENT

This group will receive 7.5 grams of pectin supplements twice daily for four weeks.

Pectin

Maltodextrin DIETARY_SUPPLEMENT

This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Interventions

Pectins; maltodextrin

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• A.A.M. Masclee, Professor

  Department of Internal Medicine, Division of Gastroenterology-Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 3, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 15, 2016

Record last verified: 2015-10

Locations

NL (1)