Clinical trial NCT03901157: Repetitive Lipid Intake and Food Intake
Official title: The Effect of Repetitive Intake of Lipids in Alginate Gel on Food Intake and Satiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Satiation
Overweight and Obesity
Satiety Response
Keywords: satiety
lipids in alginate gel
food intake
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

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.

Primary outcomes:
measure: Repetitive effect on ad libitum food intake
timeFrame: 4 days
Secondary outcomes:
measure: Acute effect on ad libitum food intake
timeFrame: 3 and 6 hours
measure: Acute vs repetitive on ad libitum food intake
timeFrame: 1 day and 4 days
measure: Food intake in normal living setting
timeFrame: 2 and 3 days
measure: Feelings of satiety and GI symptoms (VAS scores)
timeFrame: 1 day and 4 days
measure: Energy intake compensation
timeFrame: 1 day and 4 days
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: Centre for Healthy Eating and Food Innovation
state: Limburg
Study officials:
affiliation: Maastricht University
name: Freddy Troost, Dr.
role: PRINCIPAL_INVESTIGATOR
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