DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly

NCT02451163 | Completed Phase 2

• 1 other identifier: Fib-CC-2014
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to measure the effect of wheat polysaccharides on the occurence of common cold (CC) in elderly during a 12-week consumption period.

Conditions

Upper Respiratory Infections; Common Cold

Outcome Measures

Primary Outcomes (1)

• Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis

  Occurrence of common cold (= number of subjects affected by at least one common cold episode during intervention) according to self-reporting (questionnaire based on Jackson et al. 1958) and physicians diagnosis.

  12 weeks

Secondary Outcomes (1)

• Cumulative severity of common cold episodes

  12 weeks

Study Arms (2)

polysaccharides from wheat

ACTIVE COMPARATOR

12.0 g powder containing 10.0 g active ingredient (wheat polysaccharides) as well as 2.0 g filling substance (maltodextrin) stirred in milk or filtered apple juice (200 ml each).

Dietary Supplement: wheat polysaccharides

control product

PLACEBO COMPARATOR

12.0 g maltodextrin stirred in milk or filtered apple juice (200 ml each).

Dietary Supplement: maltodextrin

Interventions

wheat polysaccharides DIETARY_SUPPLEMENT

Consumed once daily for 12 weeks.

polysaccharides from wheat

maltodextrin DIETARY_SUPPLEMENT

Consumed once daily for 12 weeks.

control product

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and postmenopausal women aged ≥ 50
• willingness to abstain as far as possible from food and supplements containing probiotics, prebiotic supplements, other fermented products, supplements containing vitamins and minerals as well as willingness to sustain a low dietary fibre diet for 14 weeks
• written informed consent

You may not qualify if:

• subjects currently enrolled in another clinical study
• surgery or intervention requiring general anaesthesia within 2 months before the study
• current symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract
• history of allergic rhinitis, allergic asthma, anaphylactic shock, quincke edema, food allergy (type I allergy)
• allergy or hypersensitivity to any component of the test product (e. g. wheat, corn)
• known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
• active autoimmune diseases
• severe chronic disease (COPD, respiratory insufficiency, cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, severe renal, hepatic or cardiac diseases)
• known coeliac disease (gluten enteropathy)
• diabetes mellitus
• other chronic treatments likely to interfere with study outcome: e.g. laxatives, body weight management and/or medication
• chronic abdominal pain
• bowel movement less than 3 times per week
• subjects, who meet 2 or more Rome III criteria for constipation or who take laxatives on a regular basis
• vegetarian, vegan diet

Sponsors & Collaborators

• Clinical Research Center Kiel GmbH: lead
• BioActor: collaborator
• European Commission: collaborator

Study Sites (1)

Clinical Research Center (CRC) Kiel GmbH

Kiel, Schleswig-Holstein, 24118, Germany

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Christiane Laue, MD

  Clinical Research Center Kiel GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: May 19, 2015
• First Posted: May 21, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

DE (1)