Overweight and Obesity Clinical Trial
Official title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Centre for Healthy Eating and Food Innovation | Venlo | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
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* Note: There are 53 references in all — Click here to view all references
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 |
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