Obesity Clinical Trial
Official title:
The Impact of Dietary Fibres on Pancreatic Lipase Activity and Gastrointestinal Function
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.
Obesity is a rapidly growing health concern in the Western world. Modifications to diet and
lifestyle have been shown to benefit weight loss and weight management, but are often
difficult for people to adhere to over a long period. Pharmacological treatments (such as
Orlistat the most commonly used anti-obesity drug in the UK) also benefit weight loss, but
are expensive to the National Health Service (NHS), and patients often stop taking them due
to unwanted gastrointestinal side effect such as diarrhoea and incontinence. Orlistat acts by
reducing absorption of dietary fat. Dietary fibre is a term used to describe a divergent
range of indigestible compounds of plant origin consumed in the diet that have varied effects
on the human body. Recent studies have shown that some types of seaweed dietary fibre
(alginates) may act to reduce the rate of fat digestion under similar conditions to the human
gut. These fibres have also been easily incorporated into loaves of bread by a local bakers,
and were also noted to produce a better tasting product with an increased shelf life. People
who tasted the bread were unable to tell it apart from a normal white loaf. Alongside the
other better characterised benefits of dietary fibre consumption, such as reduced disease
risk and better regularity, these dietary fibres may be an ideal candidate to include in a
range of commonly eaten foods as a potential means of reducing dietary fat uptake, and
thereby benefitting weight loss and weight maintenance. Within the investigators laboratory
studies, assessments of which dietary fibre types are best at reducing fat absorption have
been made. The aim is to test the proof of principal that this occurs in the human gut, and
that foods incorporating these fibres are well-liked and do not cause unwanted
gastrointestinal side effects in two separate participant based studies. This study will test
whether the best candidate fibres from the investigators laboratory studies show the ability
to reduce fat absorption rates in humans. To do this, the fluid leaving the small intestine
of ileostomy patients will be analysed over a five hour period following ingestion of a test
meal either with or without the best candidate fibres. Both the researchers and the
participants will be blinded as to whether the particular meal the participant is consuming
is the one with added fibre or not. The participants will then return at least seven days
after the first test meal to consume the other test meal.
Up to 40 free-living adults will be recruited who have previously been through ileostomy
surgery at least two years prior to recruitment. Participants will come to the Clinical
Research Facility (CRF) and the Royal Victoria Infirmary (RVI) Newcastle for an induction
visit, and two separate study visits, at least two weeks apart.
At the induction visit, participants will have a chance to ask the research team members any
questions they may have on the study. The research staff member will describe what the
participant will have to do within the study in full. A pack will be provided to the
participant containing two standard meals and water, which the participant will be asked to
consume the night before attending for their two study visits. Informed consent will also be
taken at this visit.
Both study visits will be at the same time of day, and will be morning visits (starting 10am
or before). The evening before each study visit, participants will consume the standard meal
at a set time. The participant will then not have anything else to eat or drink until the
study visit (we will provide participants with a bottle of water to drink on the morning of
the visit, so that they stay hydrated). At each visit, participants will be provided with a
set meal that includes additional dietary fat included (e.g. slices of toast with margarine).
At one visit, participants will consume a standard meal, at the other they will consume the
same meal with added dietary fibres. Neither the participant nor the researchers will know
which meal they are receiving at each visit. These will be randomly labelled and allocated by
an independent researcher (who will not have access to participant identifiable information).
This type of study is referred to as a double-blind, placebo- controlled trial.
Participants will be asked to fill out questionnaires on their general well-being, abdominal
pain and gut health, and feeling of fullness before and after the study meal (every 30
minutes) over a five hour period. At these 30 minute time- points, ileostomy effluent bags
will be provided to the participant to replace. The collected effluent will be separated into
small vials and anonymised by the researchers. This will then be frozen until it can be
analysed later. These samples will be analysed for fat content, carbohydrate content and
amount and activity of digestive enzymes and associated compounds (such as bile acids).
At consent, participants will be asked if they would be willing to provide blood samples
during the study visits. If they are happy to do this, samples will be taken at hourly
intervals over this five hour time period in order to assess the rate of appearance of fats
and glucose into the bloodstream. Such samples will be analysed at an accredited Biochemistry
laboratory within the hospital. Any results that fall outside of the normal ranges in initial
fasting samples will be reported to participants and their General Practitioner (GP)
immediately, and participants will be withdrawn from the study. The result of these fasting
blood samples will also be sent to both GP and participants following their completion of the
study.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |