Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT00739362

Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

148

Participants Needed

1

Research Sites

914 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time. Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg/m(2) or more and weigh less than 350 pounds. Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly. After the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS. ...

CONDITIONS

Official Title

Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI >= 25 kg/m^2
  • Age 18 to 60 years
  • Right-handed
  • Weight stable (±5 percent) for the last 3 months as reported by the volunteer
Not Eligible

You will not qualify if you...

  • Weight over 300 pounds (136 kg), except if body size allows fitting in MRI machine
  • Use of medication affecting metabolism or appetite in the last 3 months
  • Current pregnancy, pregnancy within past 6 months, or current lactation
  • History or symptoms of acute or chronic disorders affecting appetite or energy use (e.g., diabetes, Cushing's disease, thyroid disorders)
  • Gastrointestinal diseases such as inflammatory bowel disease, malabsorption syndromes, or active gastric ulcer
  • Current unstable medical conditions including hepatitis, kidney problems, recent cancer treatment, or central nervous system disorders
  • Evidence of alcohol abuse (AUDIT score ≥ 8)
  • Use of drugs such as amphetamines, cocaine, heroin, or marijuana
  • Tobacco use exceeding very low dependence (Fagerstrom score > 2)
  • Postmenopausal women or symptoms of perimenopause
  • Any conditions that prevent safe MRI scanning (e.g., pacemaker, metal in the skull, severe claustrophobia)
  • Any condition that might interfere with the study or pose safety risks as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

NIDDK, Phoenix

Phoenix, Arizona, United States, 85014

Actively Recruiting

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Research Team

K

Kat A Ware

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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