The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-03-31

Brief Summary

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Wheat germ is a by-product of the wheat-milling industry with high nutritional value and therefore could be used as a raw source for the preparation of food products such as bread, cookies, muffins, etc.

The aim of this study is to assess the effects of ingesting wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.

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Detailed Description

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This is a crossover, double blinded, placebo controlled randomized trial. The study will compare the effect of consumption of wheat breads with or without wheat germ on healthy individuals, during 2 intake periods of 4 weeks each and 5 weeks washout before crossover.

The study will focus on the effects of wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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wheat bread with wheat germ

wheat bread with wheat germ supplementation

Group Type EXPERIMENTAL

wheat bread with wheat germ

Intervention Type DIETARY_SUPPLEMENT

wheat bread without wheat germ

wheat bread without wheat germ supplementation

Group Type PLACEBO_COMPARATOR

wheat bread without wheat germ

Intervention Type DIETARY_SUPPLEMENT

Interventions

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wheat bread with wheat germ

Intervention Type DIETARY_SUPPLEMENT

wheat bread without wheat germ

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Adult men or women
* Age 18 - 60 years
* Healthy volunteers free of chronic diseases with relevant effect on the gastrointestinal system or on visceral motility
* Without a diagnosis of any digestive disease including functional bowel disorders such as IBS
* Non-diabetic, no gastric bypass surgery
* Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
* Non-smoker
* Willing and able to provide written informed consent

Exclusion Criteria

* Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
* Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
* Subjects with stool frequency of ≤ 1 stool every 7 days
* Subjects not willing to avoid pre- and probiotics for the duration of the study
* Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
* Current use of medication for lowering blood cholesterol or glucose
* Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibres)
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study
* Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results
* Known food intolerance or allergy
* Subject involved in any clinical or food study within the preceding month

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes