Obesity Clinical Trial
Official title:
Acceptability of Dietary Fibre-based Foods to Reduce Dietary Fat Uptake
Verified date | March 2018 |
Source | Newcastle University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | January 18, 2012 |
Est. primary completion date | January 18, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - healthy participants - over the age of 18 Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Newcastle University | Biotechnology and Biological Sciences Research Council |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A change in side effects with consumption of alginate bread | A change in the number gastrointestinal side effects described by the volunteers | Every day volunteers take part in the study (28 days) | |
Primary | 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 once per day for 28 days | |
Primary | 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 once per day for 28 days | |
Primary | 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 once per day for 28 days | |
Primary | 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 once per day for 28 days | |
Primary | 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 once per day for 28 days | |
Primary | 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 once per day for 28 days | |
Primary | 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 once per day for 28 days | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) | |
Secondary | 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. | Once per week at the end of each study week (4 weeks) |
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