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| Name | Class |
|---|---|
| Center for Health Technology and Services Research | OTHER |
| Project VALORINTEGRADOR financed by COMPETE (FCOMP-01-0202-FEDER-038861) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wheat bread with wheat germ | Experimental | wheat bread with wheat germ supplementation |
|
| wheat bread without wheat germ | Placebo Comparator | wheat bread without wheat germ supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wheat bread with wheat germ | Dietary Supplement |
| ||
| wheat bread without wheat germ |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mean Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to weeks 2, 4, 7, 9, 11 and 13 | A validated PAC-SYM questionnaire will be used. PAC-SYM is a 12-item, self-administered questionnaire used to measure severity of symptoms over the past 2 weeks in patients with constipation. The PAC-SYM questionnaire has been demonstrated and documented to have internal consistency, reproducibility, validity, sensitivity, and responsiveness. PAC-SYM items are rated on a 5-point scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe) and grouped into three subscales related to abdominal symptoms (bloating, discomfort, pain, and cramps), stool symptoms (incomplete bowel movement, false alarm, straining, too hard, and too small), and rectal symptoms (painful bowel movement, burning, and bleeding or tearing). The total score and subscale scores are computed by taking the mean of item responses (score range 0-4). A reduction in score reflects an improvement in symptoms. Cultural adaptation and linguistic validation of the PAC-SYM for Portugal was performed by Mapi Research. | 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 | 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 | 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 | 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 | Description | Time Frame |
|---|---|---|
| Changes in mean Patient Assessment of Constipation Quality of Life (PAC-QOL) score from baseline to weeks 2, 4, 7, 9, 11 and 13 | A validated PAC-QOL questionnaire will be used. PAC-QOL questionnaire is a 28-item self-administered questionnaire that is being used to measure health-related quality of life (over the past 2 weeks) in patients with chronic constipation. The 28 items are grouped into four subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Previous studies have shown that PAC-QOL is internally consistent, reproducible, valid and responsive to improvements in chronic constipation over time. Cultural adaptation and linguistic validation of the PAC-QOL for Portugal was performed by Mapi Research Trust. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Registration of any adverse events. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conceição Calhau, PhD | CINTESIS, Faculty of Medicine of the University of Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PtCRIN | Lisbon | Portugal | ||||
| CINTESIS - Faculty of Medicine of the University of Porto |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31325040 | Result | 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. | |
| 30659039 | Result |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dietary Supplement |
|
| Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2, 3 and 4 | 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 | 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 | 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) |
| 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 | 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 | A number scale will be used to measure the average intensity (abdominal discomfort and bloating), over the previous 24 hours, on a 5-point scale from 0 (absence of symptom) to 4 (very severe). Will be assessed through daily records. | 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 | The Bristol stool scale will be used to measure the stool consistency. Will be assessed through daily records. | 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 | Will be assessed through daily records. | 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 | 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 | A validated Perceived Stress Scale (PSS) self-administered questionnaire with 13-item will be used to measure perceived stress of respondents during the last month (Portuguese version keeps 13 of the 14 original items). The PSS questionnaire has been demonstrated to have internal consistency, reproducibility, validity, and sensitivity. Cultural adaptation and linguistic validation of the PSS for Portugal was implemented by Pais-Ribeiro & Marques (2009). | 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) |
| Porto |
| 4200-450 |
| Portugal |
| 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. |
| 28157671 | Derived | 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. |