- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05178667
Food Supplement Effect on Overweight or Moderate Obesity (PHYTOENIX)
13 de diciembre de 2022 actualizado por: Jean-Michel Lecerf, Institut Pasteur de Lille
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.
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
129
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Paris, Francia, 75013
- Institute of Cardiometabolism And Nutrition
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Nord
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Lille, Nord, Francia, 59019
- NutrInvest - Institut Pasteur de Lille
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- BMI between 25 and 35 kg / m² (limits excluded),
- Having a fat mass (measured by impedance balance in kg) according to the following table:
Men 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.
- Willing to observe dietetic plan in accordance with dietitian evaluation,
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
- Affiliated with a social security scheme.
Exclusion Criteria:
Dyslipidemia or hyperlipidemia:
- Fasting total cholesterol ≥ 3.0 g / L
- Fasting triglycerides> 2.5 g / L
- with heterozygous familial hypercholesterolemia,
- Diabetes treated or not with medication,
- With severe hepatic and / or renal impairment, liver enzyme level (ALT and / or AST) greater than 2.5 times the upper normal limit,
- TSH abnormal or not stable for at least 3 months,
- History of cardiac disease (heart attack, stroke, coronary artery disease) or chronic inflammatory disease in the previous 6 months,
- With cancer or having had cancer in the 3 years preceding the study, with the exception of basal cell cancers of the skin,
- 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,
- Taking antibiotic therapy, anti-depressant treatment or treatment related to anxiety in the month preceding the study,
- Taking anti-depressant treatment or treatment related to anxiety Subject in a state of depression,
- Weight loss treatment in the previous 6 months or having followed a specific treatment promoting weight loss,
- Non stable weight during the last 6 months (>5% change in total weight),
- With metal implant (to allow DEXA measurement),
- Blood donation in the month before the start of the study and during the study,
- 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,
- 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,
- Following a particular diet (vegan),
- Diagnosed eating disorders (bulimia, anorexia nervosa, vomiting),
- Intense sport exercise practice (physical activity more than 4 hours per week) or not willing to maintain their exercise practises stable during the test,
- Smoking more than 5 cigarettes per day, unstable cigarettes consumption, or smoking cessation during 6 months preceding the inclusion or during the test,
- Bariatric surgery or who has a gastroplasty ring,
- Consuming more than 2 (women) or 3 (men) standard drinks of alcoholic beverage daily,
- Consuming illicit drugs,
- Using topical anti-cellulite treatments,
- For woman: Pregnant or planned to become, breastfeeding, with non-effective contraception,
- Known allergy to one of the component of the supplement (carrot and rose hip),
- 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,
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: High dose
4 capsules with 1.6g of active product per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
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Comparador activo: Low dose
4 capsules with 0.8g of active product per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
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Comparador de placebos: Maltodextrin
4 placebo capsules (maltodextrin) per day: 2 at breakfast and 2 at dinner
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Food supplements are consumed during 3 months by healthy volunteers.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline weight at 3 months
Periodo de tiempo: 0 month (inclusion), 3 months
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Weight (unit: kg)
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0 month (inclusion), 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body mass composition by DEXA (dual energy x-ray absorptiometry)
Periodo de tiempo: 0 month (inclusion), 3 months
|
Lean body mass, total fat mass, subcutaneous fat mass, visceral fat mass (unit: g)
|
0 month (inclusion), 3 months
|
|
Anthropometric parameters
Periodo de tiempo: 0 month (inclusion), 1 month, 2 months, 3 months
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Hip circumference, waist circumference and thigh circumference (unit: cm)
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0 month (inclusion), 1 month, 2 months, 3 months
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Fasting glycemia
Periodo de tiempo: 0 month (inclusion), 3 months
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Carbohydrate metabolism: Fasting glycemia (unit: g/l)
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0 month (inclusion), 3 months
|
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Insulinemia
Periodo de tiempo: 0 month (inclusion), 3 months
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Carbohydrate metabolism: Insulinemia (unit: mU/l)
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0 month (inclusion), 3 months
|
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HbA1c
Periodo de tiempo: 0 month (inclusion), 3 months
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Carbohydrate metabolism: HbA1c (unit: percent)
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0 month (inclusion), 3 months
|
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HOMA index
Periodo de tiempo: 0 month (inclusion), 3 months
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Carbohydrate metabolism: determination of the HOMA index (calculated)
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0 month (inclusion), 3 months
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Lipid metabolism
Periodo de tiempo: 0 month (inclusion), 3 months
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Total cholesterol, HDL, LDL, Triglycerides (unit: g/l)
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0 month (inclusion), 3 months
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Free fatty acids
Periodo de tiempo: 0 month (inclusion), 3 months
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Lipid metabolism: free fatty acids (unit: micromol/l)
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0 month (inclusion), 3 months
|
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Hepatic metabolism
Periodo de tiempo: 0 month (inclusion), 3 months
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Creatinine (unit: mg/l)
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0 month (inclusion), 3 months
|
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Transaminases
Periodo de tiempo: 0 month (inclusion), 3 months
|
Hepatic metabolism: ASAT/ALAT (unit: UI/l)
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0 month (inclusion), 3 months
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Sedimentation rate
Periodo de tiempo: 0 month (inclusion), 3 months
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Blood parameters: Sedimentation rate (unit: mm)
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0 month (inclusion), 3 months
|
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Blood count
Periodo de tiempo: 0 month (inclusion), 3 months
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Blood parameters: Blood count (unit: G/L)
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0 month (inclusion), 3 months
|
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Thyroid Stimulating Hormone
Periodo de tiempo: 0 month (inclusion), 3 months
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TSH (Thyroid Stimulating Hormone) (unit: mUI/l)
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0 month (inclusion), 3 months
|
|
High sensible C-reactive protein
Periodo de tiempo: 0 month (inclusion), 3 months
|
CRPhs (high sensible C-reactive protein) (unit: mg/l)
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0 month (inclusion), 3 months
|
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Heart rate
Periodo de tiempo: 0 month (inclusion), 1 month, 2 months, 3 months
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Hemodynamic parameters: Heart rate (unit: Pul/min)
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0 month (inclusion), 1 month, 2 months, 3 months
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Blood pressure
Periodo de tiempo: 0 month (inclusion), 1 month, 2 months, 3 months
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Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)
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0 month (inclusion), 1 month, 2 months, 3 months
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Body mass composition by impedancemetry
Periodo de tiempo: 0 month (inclusion), 1 month, 2 months, 3 months
|
Lean body mass and total fat mass (unit: percent)
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0 month (inclusion), 1 month, 2 months, 3 months
|
|
Weight
Periodo de tiempo: 0 month (inclusion), 1 month, 2 months, 3 months
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Anthropometric parameters: weight (unit: kg)
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0 month (inclusion), 1 month, 2 months, 3 months
|
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Height
Periodo de tiempo: 0 month (inclusion), 1 month, 2 months, 3 months
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Anthropometric parameters: height (unit: cm)
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0 month (inclusion), 1 month, 2 months, 3 months
|
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Body Mass Index
Periodo de tiempo: 0 month (inclusion), 1 month, 2 months, 3 months
|
Anthropometric parameters: determined Body Mass Index (unit: kg/m²)
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0 month (inclusion), 1 month, 2 months, 3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de enero de 2022
Finalización primaria (Actual)
31 de octubre de 2022
Finalización del estudio (Actual)
31 de octubre de 2022
Fechas de registro del estudio
Enviado por primera vez
1 de diciembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
16 de diciembre de 2021
Publicado por primera vez (Actual)
5 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de diciembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
13 de diciembre de 2022
Última verificación
1 de diciembre de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2021-A02422-39
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .