Pectin, Aging and Intestinal Barrier Function

NCT ID: NCT02376270

Last Updated: 2016-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Pectin

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

Group Type: EXPERIMENTAL

Pectin

Intervention Type: DIETARY_SUPPLEMENT

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

Maltodextrin

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

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Pectin

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

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

A.A.M. Masclee, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Division of Gastroenterology-Hepatology

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

143055

Identifier Type: -

Identifier Source: org_study_id