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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stated willingness to comply with all study procedures and availability for the duration of the study.

18-60 years of age.

Able to read and understand English proficiently (to be able to complete the multiple study questionnaires and instruments).

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

110 Participants
are grouped into 1 trial group
Group A: Healthy Volunteer

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 10
2

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.

Time frame
Day 10

Secondary outcomes

1

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

Physical activity values and trajectories from the 10-day outpatient research accelerometer assessment

Time frame
Day 10
2

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

Resting metabolic rate and respiratory quotient values obtained from the metabolic hood.

Time frame
Day 10
3

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

Glucose values and trajectories from fasting labs, OGTT, and 10-day outpatient CGM assessment, including mean, standard deviation, area-under-the-curve, and estimated a1c

Time frame
Day 10
4

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

Telomere length (t/s ratio)

Time frame
Day 10

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: