Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 7:02 AM
Study NCT ID:
NCT03901157
Status:
UNKNOWN
Last Update Posted:
2020-02-24
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Lipid Intake and Food Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repetitive effect on ad libitum food intake', 'timeFrame': '4 days', '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.'}], 'secondaryOutcomes': [{'measure': 'Acute effect on ad libitum food intake', 'timeFrame': '3 and 6 hours', '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.'}, {'measure': 'Acute vs repetitive on ad libitum food intake', 'timeFrame': '1 day and 4 days', '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).'}, {'measure': 'Food intake in normal living setting', 'timeFrame': '2 and 3 days', '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.'}, {'measure': 'Feelings of satiety and GI symptoms (VAS scores)', 'timeFrame': '1 day and 4 days', '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).'}, {'measure': 'Energy intake compensation', 'timeFrame': '1 day and 4 days', 'description': 'Percentage of energy intake compensation at lunch and dinner.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['satiety', 'lipids in alginate gel', 'food intake'], 'conditions': ['Satiation', 'Overweight and Obesity', 'Satiety Response']}, 'referencesModule': {'references': [{'pmid': '24533218', 'type': 'BACKGROUND', 'citation': 'Blomain ES, Dirhan DA, Valentino MA, Kim GW, Waldman SA. 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Epub 2012 May 30.'}, {'pmid': '30824401', 'type': 'BACKGROUND', 'citation': 'Corstens MN, Troost FJ, Alleleyn AME, Klaassen T, Berton-Carabin CC, Schroen K, Masclee AAM. Encapsulation of lipids as emulsion-alginate beads reduces food intake: a randomized placebo-controlled cross-over human trial in overweight adults. Nutr Res. 2019 Mar;63:86-94. doi: 10.1016/j.nutres.2018.12.004. Epub 2018 Dec 8.'}, {'pmid': '32625343', 'type': 'BACKGROUND', 'citation': 'EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Younes M, Aggett P, Aguilar F, Crebelli R, Filipic M, Frutos MJ, Galtier P, Gott D, Gundert-Remy U, Kuhnle GG, Lambre C, Leblanc JC, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Waalkens-Berendsen I, Woutersen RA, Wright M, Brimer L, Lindtner O, Mosesso P, Christodoulidou A, Horvath Z, Lodi F, Dusemund B. Re-evaluation of alginic acid and its sodium, potassium, ammonium and calcium salts (E 400-E 404) as food additives. 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Epub 2014 Aug 7.'}, {'pmid': '25216051', 'type': 'BACKGROUND', 'citation': 'van der Wielen N, van Avesaat M, de Wit NJ, Vogels JT, Troost F, Masclee A, Koopmans SJ, van der Meulen J, Boekschoten MV, Muller M, Hendriks HF, Witkamp RF, Meijerink J. Cross-species comparison of genes related to nutrient sensing mechanisms expressed along the intestine. PLoS One. 2014 Sep 12;9(9):e107531. doi: 10.1371/journal.pone.0107531. eCollection 2014.'}, {'pmid': '4061357', 'type': 'BACKGROUND', 'citation': 'Koopmans HS. Satiety signals from the gastrointestinal tract. Am J Clin Nutr. 1985 Nov;42(5 Suppl):1044-9. doi: 10.1093/ajcn/42.5.1044.'}], 'seeAlsoLinks': [{'url': 'http://www.who.int/mediacentre/factsheets/fs311/en/', 'label': 'Obesity and overweight'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Based on medical history and previous examination, no serious gastrointestinal complaints can be defined;\n* Age between 18 and 65 years. This study will include healthy adult subjects (male and female);\n* BMI between 25-30 kg/m2;\n* Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions;\n* Weight stable over at least the last 6 months (self-admitted; ≤5% weight change).\n\nExclusion Criteria:\n\n* Self-admitted milk (-protein or lactose)- allergy/intolerance;\n* 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;\n* 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;\n* 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;\n* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery) upon judgement of the principal investigator;\n* Dieting (medically prescribed, diabetic and vegetarian);\n* Pregnancy, lactation (both self-admitted);\n* Excessive alcohol consumption (\\>20 alcoholic units per week);\n* Smoking;\n* Self-admitted HIV-positive state.'}, 'identificationModule': {'nctId': 'NCT03901157', 'briefTitle': 'Repetitive Lipid Intake and Food Intake', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Repetitive Intake of Lipids in Alginate Gel on Food Intake and Satiety', 'orgStudyIdInfo': {'id': 'NL66473.068.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active yogurt', 'description': 'Contains 120 g yogurt + 60 g oil-gel particles (containing 6 g oil) + 24 g water', 'interventionNames': ['Dietary Supplement: Yogurt A: Active']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control yogurt', 'description': 'Contains 120 g yogurt + 54 g empty gel particles + 6 g oil in 24 g water', 'interventionNames': ['Dietary Supplement: Yogurt B: Control']}], 'interventions': [{'name': 'Yogurt A: Active', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Free fat yogurt containing oil-filled alginate gels', 'armGroupLabels': ['Active yogurt']}, {'name': 'Yogurt B: Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels', 'armGroupLabels': ['Control yogurt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5928 RC', 'city': 'Venlo', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Alvaro R Garcia Fuentes, MSc.', 'role': 'CONTACT', 'email': 'a.garciafuentes@maastrichtuniversity.nl', 'phone': '+31 (0)43-3883182'}], 'facility': 'Centre for Healthy Eating and Food Innovation', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}], 'centralContacts': [{'name': 'Alvaro R Garcia Fuentes', 'role': 'CONTACT', 'email': 'a.garciafuentes@maastrichtuniversity.nl', 'phone': '+31433883182'}], 'overallOfficials': [{'name': 'Freddy Troost, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}