Back to resultsRepetitive Lipid Intake and Food Intake
Primary Purpose
Satiation, Overweight and Obesity, Satiety Response
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Yogurt A: Active
Yogurt B: Control
Sponsored by
About this trial
This is an interventional prevention trial for Satiation focused on measuring satiety, lipids in alginate gel, food intake
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.
Sites / Locations
- Centre for Healthy Eating and Food InnovationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active yogurt
Control yogurt
Arm Description
Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water
Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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).
Energy intake compensation
Percentage of energy intake compensation at lunch and dinner.
Full Information
NCT ID
NCT03901157
First Posted
April 2, 2019
Last Updated
February 21, 2020
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03901157
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Satiation, Overweight and Obesity, Satiety Response
Keywords
satiety, lipids in alginate gel, food intake
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active yogurt
Arm Type
Experimental
Arm Description
Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water
Arm Title
Control yogurt
Arm Type
Active Comparator
Arm Description
Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt A: Active
Intervention Description
Free fat yogurt containing oil-filled alginate gels
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt B: Control
Intervention Description
Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels
Primary Outcome Measure Information:
Title
Repetitive effect on ad libitum food intake
Description
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.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Acute effect on ad libitum food intake
Description
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.
Time Frame
3 and 6 hours
Title
Acute vs repetitive on ad libitum food intake
Description
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).
Time Frame
1 day and 4 days
Title
Food intake in normal living setting
Description
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.
Time Frame
2 and 3 days
Title
Feelings of satiety and GI symptoms (VAS scores)
Description
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).
Time Frame
1 day and 4 days
Title
Energy intake compensation
Description
Percentage of energy intake compensation at lunch and dinner.
Time Frame
1 day and 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alvaro R Garcia Fuentes
Phone
+31433883182
Email
a.garciafuentes@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freddy Troost, Dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Healthy Eating and Food Innovation
City
Venlo
State/Province
Limburg
ZIP/Postal Code
5928 RC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvaro R Garcia Fuentes, MSc.
Phone
+31 (0)43-3883182
Email
a.garciafuentes@maastrichtuniversity.nl
12. IPD Sharing Statement
Plan to Share IPD
No
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Results Reference
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Links:
URL
http://www.who.int/mediacentre/factsheets/fs311/en/
Description
Obesity and overweight
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Repetitive Lipid Intake and Food Intake
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