Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT05178667
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2021-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Supplement Effect on Overweight or Moderate Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003276', 'term': 'Contraceptives, Oral'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-16', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline weight at 3 months', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Weight (unit: kg)'}], 'secondaryOutcomes': [{'measure': 'Body mass composition by DEXA (dual energy x-ray absorptiometry)', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)'}, {'measure': 'Anthropometric parameters', 'timeFrame': '0 month (inclusion), 1 month, 2 months, 3 months', 'description': 'Hip circumference, waist circumference and thigh circumference (unit: cm)'}, {'measure': 'Fasting glycemia', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Carbohydrate metabolism: Fasting glycemia (unit: g/l)'}, {'measure': 'Insulinemia', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Carbohydrate metabolism: Insulinemia (unit: mU/l)'}, {'measure': 'HbA1c', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Carbohydrate metabolism: HbA1c (unit: percent)'}, {'measure': 'HOMA index', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Carbohydrate metabolism: determination of the HOMA index (calculated)'}, {'measure': 'Lipid metabolism', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)'}, {'measure': 'Free fatty acids', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Lipid metabolism: free fatty acids (unit: micromol/l)'}, {'measure': 'Hepatic metabolism', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Creatinine (unit: mg/l)'}, {'measure': 'Transaminases', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Hepatic metabolism: ASAT/ALAT (unit: UI/l)'}, {'measure': 'Sedimentation rate', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Blood parameters: Sedimentation rate (unit: mm)'}, {'measure': 'Blood count', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'Blood parameters: Blood count (unit: G/L)'}, {'measure': 'Thyroid Stimulating Hormone', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'TSH (Thyroid Stimulating Hormone) (unit: mUI/l)'}, {'measure': 'High sensible C-reactive protein', 'timeFrame': '0 month (inclusion), 3 months', 'description': 'CRPhs (high sensible C-reactive protein) (unit: mg/l)'}, {'measure': 'Heart rate', 'timeFrame': '0 month (inclusion), 1 month, 2 months, 3 months', 'description': 'Hemodynamic parameters: Heart rate (unit: Pul/min)'}, {'measure': 'Blood pressure', 'timeFrame': '0 month (inclusion), 1 month, 2 months, 3 months', 'description': 'Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)'}, {'measure': 'Body mass composition by impedancemetry', 'timeFrame': '0 month (inclusion), 1 month, 2 months, 3 months', 'description': 'Lean body mass and total fat mass (unit: percent)'}, {'measure': 'Weight', 'timeFrame': '0 month (inclusion), 1 month, 2 months, 3 months', 'description': 'Anthropometric parameters: weight (unit: kg)'}, {'measure': 'Height', 'timeFrame': '0 month (inclusion), 1 month, 2 months, 3 months', 'description': 'Anthropometric parameters: height (unit: cm)'}, {'measure': 'Body Mass Index', 'timeFrame': '0 month (inclusion), 1 month, 2 months, 3 months', 'description': 'Anthropometric parameters: determined Body Mass Index (unit: kg/m²)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of a food supplement containing extracts of carrot and rose hip seeds on the weight of volunteers with overweight or moderate obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI between 25 and 35 kg / m² (limits excluded),\n* Having a fat mass (measured by impedance balance in kg) according to the following table:\n\nMen 18-29 years : ≥ 21.2 kg; Men 30-49 years : ≥ 21.6 kg; Men 50-65 years : ≥ 23.8 kg; Women 18-29 years : ≥ 31.4 kg; Women30-49 years : ≥ 31.8 kg; Women 50-65 years : ≥ 33.9 kg.\n\n* Willing to observe dietetic plan in accordance with dietitian evaluation,\n* Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,\n* Affiliated with a social security scheme.\n\nExclusion Criteria:\n\n* Dyslipidemia or hyperlipidemia:\n\n * Fasting total cholesterol ≥ 3.0 g / L\n * Fasting triglycerides\\> 2.5 g / L\n * with heterozygous familial hypercholesterolemia,\n* Diabetes treated or not with medication,\n* With severe hepatic and / or renal impairment, liver enzyme level (ALT and / or AST) greater than 2.5 times the upper normal limit,\n* TSH abnormal or not stable for at least 3 months,\n* History of cardiac disease (heart attack, stroke, coronary artery disease) or chronic inflammatory disease in the previous 6 months,\n* With cancer or having had cancer in the 3 years preceding the study, with the exception of basal cell cancers of the skin,\n* Taking drugs known to have an impact on weight management (corticosteroids, neuroleptics, anti-HIV triple therapy, etc.) in the month preceding inclusion and / or likely to consume them during the test,\n* Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,\n* Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression,\n* Weight loss treatment in the previous 6 months or having followed a specific treatment promoting weight loss,\n* Non stable weight during the last 6 months (\\>5% change in total weight),\n* With metal implant (to allow DEXA measurement),\n* Blood donation in the month before the start of the study and during the study,\n* Consuming food supplements or functional foods known to have an influence on weight management in the month preceding the inclusion and / or likely to take during the test,\n* Following or having followed a hypocaloric diet (energy intake \\<1,500 kCal / day) in the month preceding inclusion and / or likely to undertake this diet during the test,\n* Following a particular diet (vegan),\n* Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),\n* Intense sport exercise practice (physical activity more than 4 hours per week) or not willing to maintain their exercise practises stable during the test,\n* Smoking more than 5 cigarettes per day, unstable cigarettes consumption, or smoking cessation during 6 months preceding the inclusion or during the test,\n* Bariatric surgery or who has a gastroplasty ring,\n* Consuming more than 2 (women) or 3 (men) standard drinks of alcoholic beverage daily,\n* Consuming illicit drugs,\n* Using topical anti-cellulite treatments,\n* For woman: Pregnant or planned to become, breastfeeding, with non-effective contraception,\n* Known allergy to one of the component of the supplement (carrot and rose hip),\n* Suffering from serious illnesses such as cancer, recent myocardial infarction, serious digestive pathologies or others diseases found to be inconsistent with the conduct of the study by the investigator,\n* Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,\n* Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,\n* Presenting a psychological or linguistic incapability to sign the informed consent,\n* Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject."}, 'identificationModule': {'nctId': 'NCT05178667', 'acronym': 'PHYTOENIX', 'briefTitle': 'Food Supplement Effect on Overweight or Moderate Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Institut Pasteur de Lille'}, 'officialTitle': 'Effect of Carrot Seed and Rose Hip Extracts on Weight Management in Subjects With Overweight or Moderate Obesity. A Controlled, Randomized and Double-blind Study.', 'orgStudyIdInfo': {'id': '2021-A02422-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose', 'description': '4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner', 'interventionNames': ['Dietary Supplement: High dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose', 'description': '4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner', 'interventionNames': ['Dietary Supplement: Low dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin', 'description': '4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'High dose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Food supplements are consumed during 3 months by healthy volunteers.', 'armGroupLabels': ['High dose']}, {'name': 'Low dose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Food supplements are consumed during 3 months by healthy volunteers.', 'armGroupLabels': ['Low dose']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Food supplements are consumed during 3 months by healthy volunteers.', 'armGroupLabels': ['Maltodextrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59019', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'NutrInvest - Institut Pasteur de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Institute of Cardiometabolism And Nutrition', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Michel Lecerf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur de Lille - NutrInvest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur de Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jean-Michel Lecerf', 'investigatorAffiliation': 'Institut Pasteur de Lille'}}}}