Acceptability of Dietary Fibre-based Foods

NCT03477981 | Completed

• 1 other identifier: Proposal v4 04JAN2010
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (8)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 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?

  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?

  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?

  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?

  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?

  Once per week at the end of each study week (4 weeks)

Study Arms (1)

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.

Other: Alginate bread

Interventions

Alginate bread OTHER

White bread with 4% alginate (wet weight of dough) included into the bread.

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy participants
• over the age of 18

You may not qualify if:

• 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).

Sponsors & Collaborators

• Newcastle University: lead
• Biotechnology and Biological Sciences Research Council: collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will consume their habitual diet with standard white bread for two week, then will be given the alginate bread for two weeks.

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: March 27, 2018
• Study Start: January 19, 2010
• Primary Completion: January 18, 2012
• Study Completion: January 18, 2012
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share