Repetitive Lipid Intake and Food Intake

Overweight and Obesity Clinical Trial

Official title:

The Effect of Repetitive Intake of Lipids in Alginate Gel on Food Intake and Satiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03901157
• Other study ID #: NL66473.068.19
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: October 2020

Study information

• Verified date: February 2020
• Source: Maastricht University Medical Center
• Contact: Alvaro R Garcia Fuentes
• Phone: +31433883182
• Email: a.garciafuentes[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Satiation
• Satiety Response

Intervention

Dietary Supplement:
• Yogurt A: Active
Free fat yogurt containing oil-filled alginate gels
• Yogurt B: Control
Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels

Locations

Country	Name	City	State
Netherlands	Centre for Healthy Eating and Food Innovation	Venlo	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repetitive effect on ad libitum food intake	Food intake of ad libitum meal (kcal), as measured during lunch (based on cumulated weight reduction of the food items provided) and during a pasta dinner (also based on weight reduction of the plate assuming a homogenous meal) after 4 days of consumption of the test product.	4 days
Secondary	Acute effect on ad libitum food intake	Food intake of ad libitum meal (kcal), as measured during lunch (based on cumulated weight reduction of the food items provided) and during a pasta dinner (also based on weight reduction of the plate assuming a homogenous meal) on the first day of consumption of the test product.	3 and 6 hours
Secondary	Acute vs repetitive on ad libitum food intake	The food intake on the first day of consumption of the test product (acute effect) will be compared with the food intake after 4 days of consumption of the test product (repetitive effect).	1 day and 4 days
Secondary	Food intake in normal living setting	Food intake of normal living setting (kcal), as calculated from food diaries filled by participants on day 2 and day 3 of the research periods.	2 and 3 days
Secondary	Feelings of satiety and GI symptoms (VAS scores)	Feelings of satiety and reduce feelings of hunger, as measured on VAS scores (satiety, fullness, hunger, desire to eat, desire to snack) and occurrence and severity of gastrointestinal (GI) symptoms that orally ingested lipids in alginate gel might give, as measured on VAS scores of GI symptoms (bloating, discomfort, pain, nausea).	1 day and 4 days
Secondary	Energy intake compensation	Percentage of energy intake compensation at lunch and dinner.	1 day and 4 days

External Links

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