- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03526120
Pistachio Intake, Satiety and Body Weight Control in Healthy Adult Women (APIS)
Acute Satiety and Energy Compensation After Consumption of a Pistachio Snack and Longer Term Consequences on Satiety, Anthropometry, and Body Composition After a Nutritional Intervention With Daily Consumption of the Pistachio Snack
Descripción general del estudio
Descripción detallada
The expected endpoint is to demonstrate that the daily consumption of a snack of pistachios by healthy women, as recommended in the next National Program for Nutrition and Health (program PNNS, France), elicits adequate satiety and does not induce weight gain but rather improves diet quality, body composition and body fat mass distribution (less abdominal fat).
The study will be a 16 weeks randomized controlled open trial, single-center, including two parallel groups of 30 female participants (block randomization stratified on habitual energy intake and initial body weight according to the consort-statement checklist).
The main working hypothesis is a demonstration of the "non inferiority" of the effects of the pistachio intervention on body weight versus no snack consumption. The investigators hypothesize that there will be no significant difference in body weight change due to pistachios consumption. The two-sided 95% confidence interval on the intra-patient difference (before minus after the pistachio intervention) will be provided through the appropriate contrasts.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marc FANTINO, MD, PhD, Pr.
- Número de teléfono: +33 481 653 365
- Correo electrónico: marc.fantino@creabio-ra.com
Ubicaciones de estudio
-
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Rhône
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Givors, Rhône, Francia, F-69700
- Reclutamiento
- CreaBio Rhône-Alpes
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Contacto:
- Marc Fantino, MD, PhD, Pr
- Número de teléfono: +33 481 653 365
- Correo electrónico: marc.fantino@creabio-ra.com
-
Investigador principal:
- Marc Fantino, MD, PhD, Pr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy women;
- Age: lower age limit 18 years, upper age limit: 50 years (included);
- Body Mass Index: lower limit 19 kg/m²; upper limit 29.9 kg/m²; weight stable within ± 2 kg in the last 3 months;
- Habitual energy intake, as indicated by an initial intake report (diary method, three days) within the 95% confidence interval (CI) of the habitual energy intake of a similar population (as provided by internal reference data collected by CREABio-RA from previous studies in similar conditions);
- Participant not pregnant, not presently breast feeding or having breastfed in the last 3 months, and not planning to become pregnant during the study (negative pregnancy test at inclusion or morning of V1);
- Pre-menopausal participant on effective contraception since at least 3 months (regular 28-day cycle) and who agree to continue their contraception throughout the study;
- Participant registered with the French Social Security;
- participant having signed informed consent
Exclusion Criteria:
- Subject under legal protection or deprived of liberty by judicial or administrative decision.
- Currently diagnosed somatic pathology;
- On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months;
- Major psychiatric disorder, particularly eating disorders as defined by the DSM-V;
- High level of "Restrained Eating" or "Disinhibition", as revealed by the TFEQ or similar questionnaire;
- Strong initial dislike of nuts, specially pistachios, as revealed by questioning about food habits initial dietary questionnaire;
- Habitual consumption of pistachios as revealed by the 3-d intake report (more than twice a week);
- Participants smoking more than 10 cigarettes per day or planning to stop smoking in the next 3 months;
- Currently pregnant, lactating (as specified in article L1121-5 of the Public Health Code) or less than 6 month post-partum;
- Any kind of food allergy, especially allergies or intolerance to nuts;
- Participant not capable of understanding the constraints of the study, who does not agree to abide, and/or unable to communicate normally with investigators;
- Person currently participating in another clinical study, or having used up her annual entitlement to compensation for participation in biomedical studies (4500 €).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Pistachio diet
Incorporates 44 g (1 serving) of pistachios into a daily diet
|
Dailly 44 g unsalted pistachios snack for 12 weeks
|
Sin intervención: Control
No pistachio consumption
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Peso corporal
Periodo de tiempo: 12 semanas
|
Peso corporal en kg
|
12 semanas
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Total daily energy intake
Periodo de tiempo: 12 weeks
|
Total daily energy intake in kcal
|
12 weeks
|
Appetite ratings
Periodo de tiempo: 12 weeks
|
Appetite ratings measured on visual analogic scalls of 100 mm
|
12 weeks
|
Body weight index
Periodo de tiempo: 12 weeks
|
Body weight index in kg/m2
|
12 weeks
|
Body fat mass
Periodo de tiempo: 12 weeks
|
Body fat mass in kg
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marc FANTINO, MD, PhD, Pr., CreaBio Rhône-Alpes
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- APIS
- ID RCB : 20107-A031 (Identificador de registro: Agence Nationale de Sécurité du Médicament (ANSM, France))
- APG01-0117 (Otro identificador: CreaBio-RA)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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