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

Universidade do Porto

Status and phase

Completed

Phase 2

Conditions

Healthy Volunteers

Treatments

Dietary Supplement: wheat bread with wheat germ

Dietary Supplement: wheat bread without wheat germ

Study type

Interventional

Funder types

Other

Identifiers

NCT02405507

VI001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

55 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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