Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism

NCT06690294 | Not Yet Recruiting

• 2 other identifiers: 10001980001980-DK
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Many people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults. Objective: To explore how childhood experiences affect adult eating behaviors. Eligibility: Healthy people aged 18 to 60 years. Design: Participants will have 3 clinic visits. They will be screened with blood tests. They will answer questions about their alcohol and tobacco use. At the next visit, participants will undergo these activities: Parts of their body (such as waist, neck, and thighs) will be measured with a tape. They will have an imaging scan to find out how much body fat they have. They will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days. They will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days. They will answer questions about their education, childhood, and routines. They will receive a kit to collect a stool sample at home. At the last visit, participants will have these tests: Participants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head. Blood samples will be taken before and after participants drink a sugary drink. Participants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.

Conditions

Healthy Volunteer; Obestity

Keywords

Healthy Volunteer; Obesity; Eating Behavior

Outcome Measures

Primary Outcomes (2)

• To determine whether an association exists between unpredictability schema measures and ad libitum food intake.

  Ad libitum Food Intake (kcal) measured from a buffet meal task.

  Day 10

• To determine whether an association exists between the unpredictability schema and experience scores and eating in the absence of hunger

  Eating in the absence of hunger (kcal) from a snack food taste test.

  Day 10

Secondary Outcomes (5)

• To determine whether an association exists between measures of the unpredictability schema and experience scores and physical activity.

  Day 10

• To determine whether an association exists between measures of the unpredictability schema and experience scores and resting metabolic rate and RQ.

  Day 10

• To determine whether an association exists between measures of the unpredictability schema and experience scores and glucose values (CGM and OGTT)

  Day 10

• To determine whether an association exists between measures of the unpredictability schema and experience scores and telomere length

  Day 10

• To determine whether an association exists between measures of the unpredictability schema and experience scores and with gut microbiota composition.

  Day 10

Study Arms (1)

Healthy Volunteer

adults, age 18-60 years

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will enroll healthy, non-pregnant, women and men aged 18-60 years old who are without diabetes from the Greater Phoenix area, Arizona, United States. The study anticipates screening/enrolling 310 participants to achieve a goal of 110 participants completing the study.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• years of age.
• Able to read and understand English proficiently (to be able to complete the multiple study questionnaires and instruments).

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Diabetes
• Fasting glucose \>= 126 mg/dl or HbA1c \>= 6.5% or
• Self-reported history of type 1 or type 2 diabetes.
• Endocrine disorders, such as
• Self-reported history of Cushing's disease, pituitary disorders, or hypo- and hyperthyroidism
• TSH \<0.1 or \>= 10 uIU/mL
• Pulmonary disorders
• Self-reported history of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)
• Cardiovascular diseases,
• Self-reported history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol (investigator judgment)
• Liver disease,
• Advanced liver disease (as determined by history, labs, exams, and patient self-report) that which would limit ability to follow the protocol (investigator judgment)
• AST or ALT elevations \> 3 times upper limit of normal
• Gastrointestinal Surgery

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK)

Phoenix, Arizona, 85004, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Tomas Cabeza De Baca, Ph.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Cabeza De Baca, Ph.D.

CONTACT

(301) 496-9404; tommy.cabezadebaca@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-03-27

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)