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Healthy VolunteersPhase 2NCT02405507

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

A Phase 2 study testing wheat bread with wheat germ and wheat bread without wheat germ in people with Healthy Volunteers, run by Universidade do Porto at 2 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
wheat bread with wheat germ and wheat bread without wheat germ
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
2 sitesPortugal
Study dates
Jun 2015to Mar 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Portugal2 sites

  • PtCRIN

    Lisbon

  • CINTESIS - Faculty of Medicine of the University of Porto

    Porto, 4200-450

Other trials in Portugal

About this study

Official title: The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response in Healthy Volunteers

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.

Read the 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.

Being tested
wheat bread with wheat germ, wheat bread without wheat germ
Keywords
Gastrointestinal Discomfort, Wheat germ, Constipation, Glycaemic Index, Blood Cholesterol Level, Glycaemic Response, Cholesterol, PAC-SYM, Gut Microbiota
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • wheat bread with wheat germDietary supplement

  • wheat bread without wheat germDietary supplement

Study groups in NCT02405507
Study groupRoleWhat they receive
wheat bread with wheat germExperimentalwheat bread with wheat germ supplementation
Receives: Dietary Supplement: wheat bread with wheat germ
wheat bread without wheat germPlacebo comparatorwheat bread without wheat germ supplementation
Receives: Dietary Supplement: wheat bread without wheat germ

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. Changes in fasting serum total cholesterol from baseline to visit 2, 3 and 4

    Measured: 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)

  3. Changes in fasting serum triglycerides from baseline to visit 2, 3 and 4

    Measured: 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)

  4. Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2, 3 and 4

    Measured: 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)

  5. Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2, 3 and 4

    Measured: 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)

  6. Changes in fasting serum C-reactive protein from baseline to visit 2, 3 and 4

    Measured: 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)

  7. Changes in capillary blood glucose from baseline to visit 2 and 4

    Measured: 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 (7)

  1. 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.

    Measured: 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)

  2. Changes in intestinal microbiota from baseline to visit 2, 3 and 4

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. Changes in stool frequency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13

    Will be assessed through daily records.

    Measured: 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)

  6. Changes in fasting plasma insulin from baseline to visit 2 and 4

    Measured: 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)

  7. 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).

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2016
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02405507
Sponsor's protocol ID
VI001
Status last verified
May 2017
First submitted
11 Mar 2015
Last updated
7 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31325040

  • 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.

    PubMed 30659039

  • 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.

    PubMed 28157671

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing wheat bread with wheat germ and wheat bread without wheat germ in people with Healthy Volunteers, run by Universidade do Porto at 2 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02405507, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.

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