Bioactive Dietary Fibres and Obesity

NCT03350958 | Completed

• 1 other identifier: version 2 14th Feb 2011
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obesity is a wide reaching problem in the United Kingdom (UK). 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 our laboratory suggest that types of fibre from seaweeds (alginates) can greatly reduce the rate that fat is digested in the laboratory. Our studies have identified which types of fibre are the most effective and our aim is to test whether this reduction in fat digestion is the same within the human body. This will be carried out by sampling the digestive fluid from 40 ileostomy patients over a five hour period following a test meal with and without dietary fibres. All study participants will be provided with test foods specially prepared containing the dietary fibres (e.g. in bread). We will collect data from the participants on what they have eaten and how hungry they feel.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Measurement of fat excretion in ileostomy effluent

  Measurement in grams of total lipid in ileal effluent every 30 minutes after test meal consumption

  Every 30 minutes for up to 300 minutes after test meal consumption

Secondary Outcomes (2)

• Assessment of general and gut wellbeing

  Every 30 minutes for up to 300 minutes after test meal consumption

• Measurement of circulating triacylglycerol in blood

  Every 30 minutes for up to 300 minutes after test meal consumption

Study Arms (2)

Group 1

EXPERIMENTAL

Participants received experimental test meal first and placebo comparator meal at the next study visit. Participants to fill out visit questionnaire prior to meal and every 30 minutes thereafter for 5 hours. Samples of ileostomy fluid taken at these time-points, along with blood samples in a subset of participants

Dietary Supplement: Alginate Bread; Other: Control Bread

Group 2

PLACEBO COMPARATOR

Participants received placebo comparator meal first and experimental test meal at the next study visit. Participants to fill out visit questionnaire prior to meal and every 30 minutes thereafter for 5 hours. Samples of ileostomy fluid taken at these time-points, along with blood samples in a subset of participants

Dietary Supplement: Alginate Bread; Other: Control Bread

Interventions

Alginate Bread DIETARY_SUPPLEMENT

100g Alginate Bread, toasted with 20g of butter.

Group 1; Group 2

Control Bread OTHER

100g standard White Bread (control), toasted with 20g of butter.

Also known as: Standard White bread

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Free-living
• Male or female
• Aged 18 years or above
• Have previously gone through ileostomy surgery at least two years prior, and where the ileostomy procedure is classified as fully functional and stable
• Generally healthy
• Able to fulfill study time commitments and research burden within their usual lifestyle
• In the case of the subset of participants who will give blood samples, that they are happy to provide blood samples

You may not qualify if:

• If the original reason for ileostomy (e.g. Crohn's disease, ulcerative colitis or cancer) is active during the study
• Diagnosis of major health issues, either acute or longterm
• Allergy, intolerance of dislike of any study foods

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: 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
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: As it necessary in double-blind crossover studies, neither the researchers nor the participants will know which food they are receiving at each visit. All randomisation will be carried out in anonymised fashion by an independent researcher, who will code foods and participants accordingly.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo, controlled double-blind crossover study will recruit participants (males and females, who have previously had ileostomy surgery, but currently have no health issues) from the Newcastle upon Tyne/Gateshead area. Subjects will be randomly allocated to one of two treatment groups. One group will receive a test meal containing the dietary fibre first, then on the second visit, the same meal without dietary fibre. The second group will receive the meal without dietary fibre first, followed by the meal containing dietary fibre on the second visit. For each group, the two visits will be at least 2 weeks apart. As the foods will look exactly the same (the fibres used are colourless and tasteless). As it necessary in double-blind crossover studies, neither the researchers nor the participants will know which food they are receiving at each visit. All randomisation will be carried out in anonymised fashion by an independent researcher, who will code foods and participants accordingly.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 22, 2017
• Study Start: March 10, 2011
• Primary Completion: March 7, 2013
• Study Completion: March 7, 2013
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share