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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02405507 |
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Date of registration:
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11/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response
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Scientific title:
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The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response in Healthy Volunteers |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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55 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02405507 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Conceição Calhau, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CINTESIS, Faculty of Medicine of the University of Porto |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Dietary Supplement: wheat bread without wheat germ
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Dietary Supplement: wheat bread with wheat germ
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Primary Outcome(s)
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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Secondary Outcome(s)
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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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)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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