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Reduced Caloric Intake for Insulin Resistance

N/A
Waitlist Available
Led By Ajaykumar Rao, MD
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day1 day2, day 3, day 4, day 5, day 6, day 7
Awards & highlights

Study Summary

This trial will show whether a short-term reduction in caloric intake can help reduce insulin resistance caused by days of overeating.

Who is the study for?
This trial is for healthy, non-obese men and women without diabetes, a history of obesity surgery, or significant health issues. Participants will be studied to see if reducing calories can quickly reverse insulin resistance caused by overeating.Check my eligibility
What is being tested?
The study tests whether a short-term reduction in calorie intake can lower insulin resistance that results from several days of high-calorie consumption. Volunteers undergo special tests before and after periods of both high and low caloric intake.See study design
What are the potential side effects?
There may not be direct side effects from the interventions since they involve dietary changes rather than medication. However, participants might experience hunger or fatigue with reduced caloric intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day1 day2, day 3, day 4, day 5, day 6, day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day1 day2, day 3, day 4, day 5, day 6, day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in body composition
Changes in energy expenditure
Changes in insulin resistance
+2 more
Secondary outcome measures
Changes in blood glucose levels
Changes in blood ketone levels
Changes in blood levels of free fatty acids
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: reduced caloric intakeExperimental Treatment1 Intervention
On days 5 and 6 subjects will receive 3 meals only and each meal will contain ~ 333 calories for a total of 1,000/ 24 hours.
Group II: high caloric intakeExperimental Treatment1 Intervention
Volunteers will receive 3 meals and 3 snacks over a 24 hour period which will contain ~ 6,000 calories. Main meals will consist of ~ 1,500 calories and snacks will contain ~ 500 calories.

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Who is running the clinical trial?

Temple UniversityLead Sponsor
297 Previous Clinical Trials
82,972 Total Patients Enrolled
25 Trials studying Obesity
9,413 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,240 Total Patients Enrolled
446 Trials studying Obesity
588,937 Patients Enrolled for Obesity
Ajaykumar Rao, MDPrincipal InvestigatorTemple University

Media Library

Reduced Caloric Intake Clinical Trial Eligibility Overview. Trial Name: NCT02505958 — N/A
Obesity Research Study Groups: reduced caloric intake, high caloric intake
Obesity Clinical Trial 2023: Reduced Caloric Intake Highlights & Side Effects. Trial Name: NCT02505958 — N/A
Reduced Caloric Intake 2023 Treatment Timeline for Medical Study. Trial Name: NCT02505958 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the research aim to achieve by conducting this clinical trial?

"This clinical trial seeks to evaluate Changes in insulin resistance as its primary outcome, which will be measured over a one-week period. Secondary outcomes include modifications in blood glucose levels (through daily samples analysis), glucagon concentrations (also through sampling), and ketone body concentration (again, via sample collection)."

Answered by AI

Are there any current opportunities to volunteer for this experiment?

"As per clinicaltrials.gov, this study has ceased to seek out enrollees since July 25th 2022 - when the last update was posted. The trial started enrolling on August 1st 2014. Despite the completion of recruitment for this particular experiment, there are still 1082 other trials actively accepting participants presently."

Answered by AI

Can I be an eligible participant in this experiment?

"To be eligible for the study, participants must meet certain criteria; including obesity and a range of ages falling between 18 to 70 years old. They are expecting around 100 patients in total."

Answered by AI

Does this clinical trial accept applicants who are younger than 65 years of age?

"According to the trial parameters, adults aged 18 or older and no more than 70 years old are eligible for participation."

Answered by AI

Who else is applying?

What state do they live in?
California
Pennsylvania
Georgia
What site did they apply to?
Temple University Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
How Quickly Can the Effects of Excessive Caloric Intake on Insulin Resistance be Reversed?
2014. "How Quickly Can the Effects of Excessive Caloric Intake on Insulin Resistance be Reversed?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02505958.
~0 spots leftby Apr 2025
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