Clinical trial NCT02405507: The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response
Official title: The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteers
Keywords: Gastrointestinal Discomfort
Wheat germ
Constipation
Glycaemic Index
Blood Cholesterol Level
Glycaemic Response
Cholesterol
PAC-SYM
Gut Microbiota
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Center for Health Technology and Services Research
name: Project VALORINTEGRADOR financed by COMPETE (FCOMP-01-0202-FEDER-038861)
First posted: 2015-04-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

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
timeFrame: 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)
measure: Changes in fasting serum total cholesterol from baseline to visit 2, 3 and 4
timeFrame: 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)
measure: Changes in fasting serum triglycerides from baseline to visit 2, 3 and 4
timeFrame: 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)
measure: Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2, 3 and 4
timeFrame: 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)
measure: Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2, 3 and 4
timeFrame: 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)
measure: Changes in fasting serum C-reactive protein from baseline to visit 2, 3 and 4
timeFrame: 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)
measure: Changes in capillary blood glucose from baseline to visit 2 and 4
timeFrame: 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
timeFrame: 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)
measure: Changes in intestinal microbiota from baseline to visit 2, 3 and 4
timeFrame: 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)
measure: Changes in mean daily abdominal discomfort score from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13
timeFrame: 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)
measure: Changes in stool consistency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13
timeFrame: 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)
measure: Changes in stool frequency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13
timeFrame: 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)
measure: Changes in fasting plasma insulin from baseline to visit 2 and 4
timeFrame: 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)
measure: Changes in mean Perceived Stress Scale (PSS) score from baseline to weeks 4, 9 and 13
timeFrame: 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)
Other outcomes:
measure: Adverse events
timeFrame: at visit 2 (after 4-week intake period), visit 3 (after 5-week washout period), and visit 4 (after 4-week intake period after crossover)
Locations:
city: Lisbon
country: Portugal
facility: PtCRIN
city: Porto
country: Portugal
facility: CINTESIS - Faculty of Medicine of the University of Porto
Study officials:
affiliation: CINTESIS, Faculty of Medicine of the University of Porto
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moreira-Rosario A, Marques C, Pinheiro H, Norberto S, Sintra D, Teixeira JA, Calhau C, Azevedo LF. Daily intake of wheat germ-enriched bread may promote a healthy gut bacterial microbiota: a randomised controlled trial. Eur J Nutr. 2020 Aug;59(5):1951-1961. doi: 10.1007/s00394-019-02045-x. Epub 2019 Jul 19.
citation: Moreira-Rosario A, Pinheiro H, Marques C, Teixeira JA, Calhau C, Azevedo LF. Does intake of bread supplemented with wheat germ have a preventive role on cardiovascular disease risk markers in healthy volunteers? A randomised, controlled, crossover trial. BMJ Open. 2019 Jan 17;9(1):e023662. doi: 10.1136/bmjopen-2018-023662.
citation: Moreira-Rosario A, Pinheiro H, Calhau C, Azevedo LF. Can wheat germ have a beneficial effect on human health? A study protocol for a randomised crossover controlled trial to evaluate its health effects. BMJ Open. 2016 Nov 10;6(11):e013098. doi: 10.1136/bmjopen-2016-013098.