Repetitive Lipid Intake and Food Intake

February 21, 2020 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active yogurt
Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water
Dietary supplement: Yogurt A: Active
Free fat yogurt containing oil-filled alginate gels
ACTIVE_COMPARATOR: Control yogurt
Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water
Dietary supplement: Yogurt B: Control
Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repetitive effect on ad libitum food intake
Time Frame: 4 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute effect on ad libitum food intake
Time Frame: 3 and 6 hours
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
Acute vs repetitive on ad libitum food intake
Time Frame: 1 day and 4 days
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
Food intake in normal living setting
Time Frame: 2 and 3 days
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
Feelings of satiety and GI symptoms (VAS scores)
Time Frame: 1 day and 4 days
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
Energy intake compensation
Time Frame: 1 day and 4 days
Percentage of energy intake compensation at lunch and dinner.
1 day and 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Freddy Troost, Dr., Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 21, 2019

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (ACTUAL)

April 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL66473.068.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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