Repetitive Lipid Intake and Food Intake

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Satiety Response; Overweight and Obesity; Satiation

Treatments: Dietary Supplement: Yogurt A: Active; Dietary Supplement: Yogurt B: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03901157

NL66473.068.19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Active yogurt

Experimental group

Description:

Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water

Treatment:

Dietary Supplement: Yogurt A: Active

Control yogurt

Active Comparator group

Description:

Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water

Treatment:

Dietary Supplement: Yogurt B: Control