ObesityNCT03477981
Acceptability of Dietary Fibre-based Foods
A study testing Alginate bread in people with Obesity, run by Newcastle University.
Trial summary
Obesity is a wide reaching problem in the United Kingdom. The most widely used obesity therapies are based around drugs that reduce dietary fat digestion, and thereby reduce uptake of calories from the diet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Alginate bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2010to 18 Jan 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy participants
- over the age of 18
Who cannot join
- Individuals with a known allergy to any of the study foods
- Individuals who wish not to consume the study foods)
- Individuals who will not be able to consume their standard diet over the study period (e.g. due to holidays etc).
About this study
Official title: Acceptability of Dietary Fibre-based Foods to Reduce Dietary Fat Uptake
Obesity is a wide reaching problem in the United Kingdom. The most widely used obesity therapies are based around drugs that reduce dietary fat digestion, and thereby reduce uptake of calories from the diet. While such therapies have proved effective, patient compliance is low due to the unwanted gastrointestinal side effects of these drugs. Dietary fibre is generally classified as dietary material of plant origin that is indigestible to humans. Dietary fibre is in fact a wide range of different compounds that have varied effects on the human body. Initial findings from this laboratory suggest that some types of fibre can greatly reduce the rate that fat is digested and absorbed in the gut.
Whether such fibre-based test foods are acceptable (i.e. taste good, are easy to include in the diet and do not cause any unwanted gastrointestinal side effects) will be assessed in longer term studies. To carry these studies out, healthy adults will be recruited. Participants will attend an induction visit and will be asked to keep a food diary, and fill out daily questionnaires on general well-being and feelings of fullness over a two-week period whilst consuming the standard white bread given to them. Following this two-week period, participants will attend the study centre again. At this time, participants will be provided with dietary fibre-based study food (bread) to substitute into their standard diet over the following two weeks (further bread will be provided as and when required). Participants will fill out the same diaries and questionnaires as before over the first two week period.
Read the detailed description
This study aims to test the acceptability of fibre-based foods in terms of their palatability, ease of incorporation into the diet and the lack of unwanted side effects of consumption. To meet these aims, participants will be provided with bread to incorporate into their diet (by substituting like-for-like) over a two-week period. During this time, participants will record what they have eaten, along with their general feelings of well-being throughout this period. These measures will be compared to the same data collected over the two-week period prior to giving the participants the study foods (as a "background" measure of food intake and general well-being).
To carry these studies out, healthy adults will be recruited. Participants will attend an induction visit at Newcastle University where we will take informed consent. Participants will then be asked to keep a food diary, and fill out daily questionnaires on their general well-being and feelings of fullness for the entirety of the following two weeks whilst consuming the standard white bread given to them. Following this two-week period, participants will attend the study centre again and will be provided with dietary fibre-based study food (breads) to substitute into their standard diet over the following two weeks (further foods will be provided as and when required). They will fill out the same diaries and questionnaires as they did before over the first two week period.
The wellbeing questionnaire will be filled out by participants every day with a more detailed questionnaire completed at the end of each week. Volunteers will complete the more detailed questionnaire five times. Once at the start of the study (baseline) and then at then once at the end of each week consuming standard white bread and once at the end of each week consuming the alginate bread. The standard wellbeing questionnaire will be completed every day the volunteers are on the study.
- Conditions
- Obesity
- Being tested
- Alginate bread
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alginate breadOther
White bread with 4% alginate (wet weight of dough) included into the bread.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Other | Participants will receive standard white bread for two weeks and then alginate bread for two weeks. All participants will receive the bread in the same order. Receives: Other: Alginate bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in side effects with consumption of alginate bread
A change in the number gastrointestinal side effects described by the volunteers
Measured: Every day volunteers take part in the study (28 days)
A change in visual analogue scale (VAS) score of question: How have you been feeling today, alert or sleepy?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Measured once per day for 28 days
A change in visual analogue scale (VAS) score of question: How have you been feeling today, fine or nauseous?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Measured once per day for 28 days
A change in visual analogue scale (VAS) score of question: How have you been feeling today, full or starving?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Measured once per day for 28 days
A change in visual analogue scale (VAS) score of question: How have you been feeling today, not bloated or bloated?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Measured once per day for 28 days
A change in visual analogue scale (VAS) score of question: How have you been feeling today, not flatulent or flatulent?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Measured once per day for 28 days
A change in visual analogue scale (VAS) score of question: How have you been feeling today, calm or irritable?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Measured once per day for 28 days
A change in visual analogue scale (VAS) score of question: How have you been feeling today, relaxed or anxious?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Measured once per day for 28 days
Secondary outcomes (11)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; light-headedness or dizziness, not at all or very?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; Blurred Vision, not at all or very?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; a difficulty to concentrate, not at all or very?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; excessive thirst, not at all or very?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; headaches/migraines, not at all or very?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; cravings for sweets, not at all or very?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; abdominal discomfort, not at all or very?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: bowel habit, constipated or diarrhoea?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: urgency to pass stool, less than normal more than normal?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: abdominal pain or discomfort, no pain or terrible?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: amount of flatulence, less than normal or more than normal?
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
Measured: Once per week at the end of each study week (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start19 Jan 2010
- Primary completion18 Jan 2012
- Study completion18 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Intervention model
- Sequential
- Model description
- Participants will consume their habitual diet with standard white bread for two week, then will be given the alginate bread for two weeks.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477981
- Sponsor's protocol ID
- Proposal v4 04JAN2010
- Status last verified
- Mar 2018
- First submitted
- 27 Oct 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Dietary Fibre-based Foods to Reduce Dietary Fat Uptake
- ClinicalTrials.gov ID
- NCT03477981
- Acronym / sponsor ID
- Proposal v4 04JAN2010
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Study start
- 19 Jan 2010 (actual)
- Primary completion
- 18 Jan 2012 (actual)
- Study completion
- 18 Jan 2012 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a wide reaching problem in the United Kingdom. The most widely used obesity therapies are based around drugs that reduce dietary fat digestion, and thereby reduce uptake of calories from the diet. While such therapies have proved effective, patient compliance is low due to the unwanted gastrointestinal side effects of these drugs. Dietary fibre is generally classified as dietary material of plant origin that is indigestible to humans. Dietary fibre is in fact a wide range of different compounds that have varied effects on the human body. Initial findings from this laboratory suggest that some types of fibre can greatly reduce the rate that fat is digested and absorbed in the gut.
Whether such fibre-based test foods are acceptable (i.e. taste good, are easy to include in the diet and do not cause any unwanted gastrointestinal side effects) will be assessed in longer term studies. To carry these studies out, healthy adults will be recruited. Participants will attend an induction visit and will be asked to keep a food diary, and fill out daily questionnaires on general well-being and feelings of fullness over a two-week period whilst consuming the standard white bread given to them. Following this two-week period, participants will attend the study centre again. At this time, participants will be provided with dietary fibre-based study food (bread) to substitute into their standard diet over the following two weeks (further bread will be provided as and when required). Participants will fill out the same diaries and questionnaires as before over the first two week period.
Detailed description
This study aims to test the acceptability of fibre-based foods in terms of their palatability, ease of incorporation into the diet and the lack of unwanted side effects of consumption. To meet these aims, participants will be provided with bread to incorporate into their diet (by substituting like-for-like) over a two-week period. During this time, participants will record what they have eaten, along with their general feelings of well-being throughout this period. These measures will be compared to the same data collected over the two-week period prior to giving the participants the study foods (as a "background" measure of food intake and general well-being).
To carry these studies out, healthy adults will be recruited. Participants will attend an induction visit at Newcastle University where we will take informed consent. Participants will then be asked to keep a food diary, and fill out daily questionnaires on their general well-being and feelings of fullness for the entirety of the following two weeks whilst consuming the standard white bread given to them. Following this two-week period, participants will attend the study centre again and will be provided with dietary fibre-based study food (breads) to substitute into their standard diet over the following two weeks (further foods will be provided as and when required). They will fill out the same diaries and questionnaires as they did before over the first two week period.
The wellbeing questionnaire will be filled out by participants every day with a more detailed questionnaire completed at the end of each week. Volunteers will complete the more detailed questionnaire five times. Once at the start of the study (baseline) and then at then once at the end of each week consuming standard white bread and once at the end of each week consuming the alginate bread. The standard wellbeing questionnaire will be completed every day the volunteers are on the study.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will consume their habitual diet with standard white bread for two week, then will be given the alginate bread for two weeks.
| Arm | Type | Receives |
|---|---|---|
| Study cohort | Other | Other: Alginate breadParticipants will receive standard white bread for two weeks and then alginate bread for two weeks. All participants will receive the bread in the same order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy participants
- over the age of 18
Key exclusion criteria (3 listed)
- Individuals with a known allergy to any of the study foods
- Individuals who wish not to consume the study foods)
- Individuals who will not be able to consume their standard diet over the study period (e.g. due to holidays etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alginate breadWhite bread with 4% alginate (wet weight of dough) included into the bread. | Other | Study cohort |
Primary outcome
A change in side effects with consumption of alginate bread
Time frame: Every day volunteers take part in the study (28 days)
A change in the number gastrointestinal side effects described by the volunteers
A change in visual analogue scale (VAS) score of question: How have you been feeling today, alert or sleepy?
Time frame: Measured once per day for 28 days
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
A change in visual analogue scale (VAS) score of question: How have you been feeling today, fine or nauseous?
Time frame: Measured once per day for 28 days
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
A change in visual analogue scale (VAS) score of question: How have you been feeling today, full or starving?
Time frame: Measured once per day for 28 days
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
A change in visual analogue scale (VAS) score of question: How have you been feeling today, not bloated or bloated?
Time frame: Measured once per day for 28 days
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
A change in visual analogue scale (VAS) score of question: How have you been feeling today, not flatulent or flatulent?
Time frame: Measured once per day for 28 days
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
A change in visual analogue scale (VAS) score of question: How have you been feeling today, calm or irritable?
Time frame: Measured once per day for 28 days
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
A change in visual analogue scale (VAS) score of question: How have you been feeling today, relaxed or anxious?
Time frame: Measured once per day for 28 days
Visual analogue scale (VAS) score between 0 - 10. The VAS scale is 10 cm long horizontal line and measured from the left hand side. The distance from the left hand side that the volunteer marks on the scale generates the score. The question relating to the scale will have a polar answer at each end of the VAS, as described in the title with the first answer on the left hand end and the second answer on the right hand end.
11 secondary outcomes
A change in visual analogue scale (VAS) score of question: Have you been suffering from; light-headedness or dizziness, not at all or very?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; Blurred Vision, not at all or very?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; a difficulty to concentrate, not at all or very?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; excessive thirst, not at all or very?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; headaches/migraines, not at all or very?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; cravings for sweets, not at all or very?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Have you been suffering from; abdominal discomfort, not at all or very?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: bowel habit, constipated or diarrhoea?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: urgency to pass stool, less than normal more than normal?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: abdominal pain or discomfort, no pain or terrible?
Time frame: Once per week at the end of each study week (4 weeks)
A change in visual analogue scale (VAS) score of question: Overall, how would you say the following have been: amount of flatulence, less than normal or more than normal?
Time frame: Once per week at the end of each study week (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Alginate bread in people with Obesity, run by Newcastle University.
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 2 inclusion and 3 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
A change in side effects with consumption of alginate bread (time frame: Every day volunteers take part in the study (28 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2018.