Overview

This trial is active, not recruiting.

Condition healthy volunteers
Treatments wheat bread with wheat germ, wheat bread without wheat germ
Phase phase 2
Sponsor Universidade do Porto
Collaborator Center for Health Technology and Services Research
Start date June 2015
End date October 2016
Trial size 50 participants
Trial identifier NCT02405507, VI001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
wheat bread with wheat germ supplementation
wheat bread with wheat germ
(Placebo Comparator)
wheat bread without wheat germ supplementation
wheat bread without wheat germ

Primary Outcomes

Measure
Changes in mean Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to weeks 2, 4, 7, 9, 11 and 13
time frame: at the end of week 0 (after 2-week run-in period), at the end of weeks 2 and 4 (during 4-week intake period), at the end of weeks 7 and 9 (during 5-week washout period), at the end of weeks 11 and 13 (during 4-week intake period after crossover)
Changes in fasting serum total cholesterol from baseline to visit 2, 3 and 4
time frame: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and visit 4 (after 4-week intake period after crossover)
Changes in fasting serum triglycerides from baseline to visit 2, 3 and 4
time frame: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and visit 4 (after 4-week intake period after crossover)
Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2, 3 and 4
time frame: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)
Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2, 3 and 4
time frame: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)
Changes in fasting serum C-reactive protein from baseline to visit 2, 3 and 4
time frame: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)
Changes in capillary blood glucose from baseline to visit 2 and 4
time frame: 0, 30, 60 and 120 minutes post-meal: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)

Secondary Outcomes

Measure
Changes in mean Patient Assessment of Constipation Quality of Life (PAC-QOL) score from baseline to weeks 2, 4, 7, 9, 11 and 13
time frame: at the end of week 0 (after 2-week run-in period), at the end of weeks 2 and 4 (during 4-week intake period), at the end of weeks 7 and 9 (during 5-week washout period), at the end of weeks 11 and 13 (during 4-week intake period after crossover)
Changes in intestinal microbiota from baseline to visit 2, 3 and 4
time frame: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period), and visit 4 (after 4-week intake period after crossover)
Changes in mean daily abdominal discomfort score from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13
time frame: daily during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period (weeks 5, 6, 7, 8 and 9)
Changes in stool consistency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13
time frame: at days with stool during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period ( weeks 5, 6, 7, 8 and 9)
Changes in stool frequency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13
time frame: at days with stool during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period ( weeks 5, 6, 7, 8 and 9)
Changes in fasting plasma insulin from baseline to visit 2 and 4
time frame: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)
Changes in mean Perceived Stress Scale (PSS) score from baseline to weeks 4, 9 and 13
time frame: at the end of week 0 (after 2-week run-in period), at the end of week 4 (after 4-week intake period), at the end of week 9 (after 5-week washout period), and at the end of week 13 (after 4-week intake period after crossover)

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response in Healthy Volunteers
Principal investigator Conceição Calhau, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universidade do Porto.