- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07637656
Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data
Discovering Determinants of Food Intake by Application of Machine Learning to Complex, High-Dimensional Data
Background:
Many people in the United States are overweight or obese. Researchers want to learn why some people can overeat and not gain weight, whereas others who do not overeat still gain weight.
Objective:
To study factors related to food intake that can lead to weight gain over time.
Eligibility:
Healthy adults aged 18 to 60 years.
Design:
Participants will have 6 to 8 clinic visits over 2 years. The first 3 or 4 study visits will be 1 week apart.
Procedures during visits may include the following:
Collection of blood, hair, urine, and stool samples.
Measurement of the waist, neck, thighs, and other parts of the body.
Dual energy x-ray absorption (DXA) scan: Participants will lie still on a padded table while they are scanned to measure body fat.
Physical activity monitor: Participants will wear a monitor on the wrist for 2 weeks.
Cognitive tests: Participants will perform tasks to measure attention, memory, and brain function.
Continuous glucose monitor. Participants will wear a device that measures their blood glucose for 1 week.
Mixed meal test and stomach emptying test. Participants will drink a breakfast shake and swallow a dose of acetaminophen. Blood will be drawn over the next 4 hours.
Resting metabolic rate: Participants will wear a clear hood over their head while they rest for 20 minutes. The hood will measure the gases they breathe.
Breakfast and lunch test. Participants will eat a standard breakfast. They will be allowed to select from foods and eat as much as they like at lunch. They will be asked how hungry or full they are.
Questionnaires. Participants will answer questions about their health, sleep, physical activity, and eating.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Study Description:
The study will be an outpatient study with 6-7 total visits, 3-4 completed at baseline and 3 follow-up visits, occurring over 2 years. We will collect broad, multiscale data (e.g., clinical, genetic, microbiome, energy expenditure, physical activity, psychosocial). Then, we will apply artificial intelligence algorithms with the goal of identifying novel determinants of food intake.
Objectives:
Primary Objective:
To identify novel determinants of objectively measured ad libitum energy intake using broad, multiscale data.
Secondary Objectives:
- To investigate whether determinants of ad libitum energy intake predict changes in weight, adiposity, and markers of metabolic health.
- To determine associations of metabolic measures with psychosocial, hormonal, or other metabolic markers
- To identify novel determinants of ad libitum self-reported energy and nutrient intake
Endpoints:
Primary Endpoint: Energy intake during ad libitum meal test, including total energy and macronutrient specific energy intake (e.g., carbohydrate, fat, protein) measured during the initial baseline period (visit 3). The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3.
Secondary Endpoints:
- Measures at 0.5, 1, and 2 years of body weight, BMI, fat mass, body fat percentage, HbA1c, and fasting glucose, lipids, insulin, and c-peptide.
- Psychosocial measures (visits 1-6), metabolic measures (e.g., fasting glucose, HbA1c, lipids, insulin, and c-peptide), resting metabolic rate, total energy expenditure, and physical activity
- Energy and nutrient intake from ASA-24. The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Office of Participant Recruitment (NIDDK
- Número de teléfono: (602) 200-5315
- Correo electrónico: niddkphxcontact@mail.nih.gov
Copia de seguridad de contactos de estudio
- Nombre: Susanne M Votruba, Ph.D.
- Número de teléfono: (301) 827-3521
- Correo electrónico: votrubas@niddk.nih.gov
Ubicaciones de estudio
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85004
- NIDDK, Phoenix, 850 N. 5th Street 7th Floor
-
Contacto:
- Susanne Votruba, Ph.D.
- Número de teléfono: 301-827-3521
- Correo electrónico: votrubas@niddk.nih.gov
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
- INCLUSION CRITERIA
To be eligible to participate in this study, an individual must meet all the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 to 60
- In good general health as evidenced by medical history and physical exam
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
- Weight >=204 kg (>=450 pounds, maximum weight of the iDXA machine as per manufacturer s manual), or weight <45.4 kg (<100 pounds, minimum weight allowed based on the NIH guidelines of blood drawing for research purposes)
- Unstable weight (+/-5%) within past 6 months as determined by volunteer self-report.
- Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism
- Inability to consume provided food based on food allergy or intolerance or other food restrictions (e.g., kosher, vegan, or vegetarian)
- Current pregnancy, or recent pregnancy within past 6 months or currently lactating
- History or clinical manifestation of:
6i. Diabetes, including fasting glucose >= 126 mg/dl or HbA1c >= 6.5%, or history
6ii. Surgery for treatment of obesity
6iii. Endocrine disorders, such as Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism (TSH <0.1 or >= 10 uIU/mL)
6iv. Pulmonary disorders including chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol
6v. History of coronary artery disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol
6vi. Liver disease, including cirrhosis, active hepatitis B or C based on history, and AST or ALT >= 3x normal
6vii. Gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, or other malabsorptive disorders by history
6viii. Hematologic disorders including significant anemia (male hemoglobin < 13.0 g/dL or female hemoglobin < 11.0 g/dL)
6ix. Renal disease including abnormal kidney function (eGFR <60 mL/min/1.73m^2)Subjects page 4, Eligibility Criteria
6x. Central nervous system disease, including cerebrovascular accidents, dementia, and neurodegenerative disorders by history
6xi. Cancer requiring treatment in the past 5 years, except for nonmelanoma skin cancers or cancers that have clearly been cured
6xii. Infectious disease such as active tuberculosis, HIV (by self-report), chronic coccidiomycosis or other chronic infections that might influence appetite
6xiii. Diagnosis of binge eating disorder, anorexia, or major psychiatric disorders including depression, schizophrenia, and psychosis
6xiv. Menopausal transition (late) to early postmenopause (e.g., >= 2 skipped cycles and an interval of amenorrhea >= 60 days and <12 months)
7. Alcohol abuse as defined by >= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire interview
8. Inability to provide informed consent
9. Any disorder, unwillingness, or inability not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators, such as those that jeopardize the safety of the participant or others, or would interfere with completion of study procedures
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
1
800 males and females, age 18-60 years who are in good health
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To identify novel determinants of objectively measured ad libitum energy intake using broad, multiscale data.
Periodo de tiempo: 24-28 months
|
Energy intake during ad libitum meal test, including total energy and macronutrient specific energy intake (e.g., carbohydrate, fat, protein) measured during the initial baseline period (visit 3).
The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3.
|
24-28 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To investigate whether determinants of ad libitum energy intake predict changes in weight, adiposity, and markers of metabolichealth
Periodo de tiempo: 24-48 months
|
Measures at 0.5, 1, and 2 years of body weight, BMI, fat mass,body fat percentage, HbA1c, and fasting glucose, lipids, insulin,and c-peptide.
|
24-48 months
|
|
To determine associations of metabolic measures with psychosocial, hormonal, or other metabolic markers
Periodo de tiempo: 24-48 months
|
Psychosocial measures (visits 1-6), metabolic measures (e.g., fasting glucose, HbA1c, lipids, insulin, and c-peptide), resting metabolic rate, total energy expenditure, and physical activity
|
24-48 months
|
|
To identify novel determinants of ad libitum self-reported energy and nutrient intake
Periodo de tiempo: 24-28 months
|
Energy and nutrient intake from ASA-24.
The potential determinants (broad multiscale data) will be collected during visits 1, 2, and 3
|
24-28 months
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Susanne M Votruba, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- 10001858
- 001858-DK
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.
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. .