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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Wheat Bioactives and Immune Function

NCT02210234

Endocrine, Nutritional, Metabolic and Immunity Disorders

COMPLETED NA

Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers

NCT02422537

Healthy

COMPLETED NA

Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol

NCT00981981

Hypercholesterolemia

COMPLETED PHASE2

Bioactive Phytochemicals From Wheat Bran

NCT02177279

Bio-availability of Wheat Bran Phytochemicals in the Human Gut Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation

COMPLETED NA

The Effect of Aged Garlic Extract Supplementation on Immune System

NCT01390116

Improvement in Immune Cell Function in Healthy Humans

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is conducted in the frame of the collaborative project 'FibeBiotics' (No. 289517) (Fibers as support of the Gut and Immune function of Elderly - From polysaccharide compound to health Claim) within the Seventh Framework Programme (FP7) for Research and Technological Development of the European Union (EU).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Respiratory Infections Common Cold

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

polysaccharides from wheat

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).

Group Type ACTIVE_COMPARATOR

wheat polysaccharides

Intervention Type DIETARY_SUPPLEMENT

Consumed once daily for 12 weeks.

control product

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

Group Type PLACEBO_COMPARATOR

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Consumed once daily for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

wheat polysaccharides

Consumed once daily for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

Consumed once daily for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* subjects currently enrolled in another clinical study
* subjects having finished another clinical study within the last 4 weeks before inclusion
* 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)
* chronic systemic or chronic topical treatment likely to interfere with evaluation of the study parameters: antiallergic drugs, antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, antiphlogistics (except aspirin or equivalent products preventing from aggregation of platelets or blood clotting) and steroids prescribed in chronic inflammatory diseases (in the last 4 weeks before inclusion)
* 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
* eating disorders (e.g. anorexia, bulimia)
* alcohol and drug abuse
* severe neurological, cognitive or psychiatric diseases
* subjects not understanding or speaking fluently German
* legal incapacity

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes