Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
44 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-10-21
Study Completion Date
2020-10-31
Brief Summary
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In the present study the investigators will investigate the effect of consuming lipids inside alginate gel once a day during 4 days on food intake and satiety feelings in healthy people with overweight. All participants will receive a test yogurt that includes the oil-filled Ca-alginate gels and a control yogurt where the oil is not inside the gels.
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Detailed Description
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Direct infusion of lipids into different parts of the human small intestine has demonstrated to decrease food intake and subjective appetite feelings, to increase production of the satiety hormones glucagon-like peptide 1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK), and diminishes gastrointestinal (GI) motility. Amongst oils with different degree of fatty acid saturation, safflower oil (high in linoleic acid, C18:2) was found the strongest inducer of the ileal brake. When ingested orally, however, the major part of dietary lipids will be digested and absorbed in the proximal small intestine and are not likely to induce the ileal brake mechanism. Incorporating small lipid droplets into millimeter-sized calcium (Ca)-alginate gel particles has shown promising results for ileal brake activation. Oral intake of these lipid containing gels have proven to reduce food intake in humans without inducing gastrointestinal symptoms. Contrastingly, to date little is known about repetitive activation of mechanisms of satiety and the effect on food intake. It is not known whether repetitive ileal brake activation provides a stronger brake or whether this will lead to a blunted response and adaptation.
Conditions
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Satiation
Overweight and Obesity
Satiety Response
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Study Groups
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Active yogurt
Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water
Group Type
EXPERIMENTAL
Yogurt A: Active
Intervention Type
DIETARY_SUPPLEMENT
Free fat yogurt containing oil-filled alginate gels
Control yogurt
Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water
Group Type
ACTIVE_COMPARATOR
Yogurt B: Control
Intervention Type
DIETARY_SUPPLEMENT
Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels
Interventions
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Yogurt A: Active
Free fat yogurt containing oil-filled alginate gels
Intervention Type
DIETARY_SUPPLEMENT
Yogurt B: Control
Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* Based on medical history and previous examination, no serious gastrointestinal complaints can be defined;
* Age between 18 and 65 years. This study will include healthy adult subjects (male and female);
* BMI between 25-30 kg/m2;
* Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions;
* Weight stable over at least the last 6 months (self-admitted; ≤5% weight change).
* Age between 18 and 65 years. This study will include healthy adult subjects (male and female);
* BMI between 25-30 kg/m2;
* Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions;
* Weight stable over at least the last 6 months (self-admitted; ≤5% weight change).
Exclusion Criteria
* Self-admitted milk (-protein or lactose)- allergy/intolerance;
* Self-admitted history of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided and documented by the principal investigator;
* Use of medication that can influence study end-points (to be decided by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing;
* Administration of investigational drugs or participation in any scientific intervention study that may interfere with this study, to be decided by the principal investigator prior to the study;
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery) upon judgement of the principal investigator;
* Dieting (medically prescribed, diabetic and vegetarian);
* Pregnancy, lactation (both self-admitted);
* Excessive alcohol consumption (\>20 alcoholic units per week);
* Smoking;
* Self-admitted HIV-positive state.
* Self-admitted history of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided and documented by the principal investigator;
* Use of medication that can influence study end-points (to be decided by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing;
* Administration of investigational drugs or participation in any scientific intervention study that may interfere with this study, to be decided by the principal investigator prior to the study;
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery) upon judgement of the principal investigator;
* Dieting (medically prescribed, diabetic and vegetarian);
* Pregnancy, lactation (both self-admitted);
* Excessive alcohol consumption (\>20 alcoholic units per week);
* Smoking;
* Self-admitted HIV-positive state.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Freddy Troost, Dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Centre for Healthy Eating and Food Innovation
Venlo, Limburg, Netherlands
Site Status
RECRUITING
Countries
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Netherlands
Central Contacts
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Facility Contacts
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References
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Related Links
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http://www.who.int/mediacentre/factsheets/fs311/en/
Obesity and overweight
Other Identifiers
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NL66473.068.19
Identifier Type: -
Identifier Source: org_study_id
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