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Processed vs Unprocessed Diet for Obesity

N/A
Recruiting
Led By Kevin Hall, Ph.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four 1-week diets
Awards & highlights

Study Summary

This trial is studying how processed and unprocessed foods affect metabolism and health.

Who is the study for?
Adults aged 18-60 without diabetes, stable weight, and able to exercise can join this study. They must be willing to follow the study's lifestyle guidelines for 4 weeks at NIH, including daily cycling and various health tests. Those with appetite-affecting conditions or on certain medications cannot participate.Check my eligibility
What is being tested?
The trial is testing how different diets (ultra-processed vs unprocessed foods) impact energy metabolism over a period of four weeks. Participants will eat provided meals in controlled amounts and undergo regular health assessments to measure the effects.See study design
What are the potential side effects?
This nutritional study may not have direct side effects like medication trials; however, changes in diet could potentially cause temporary digestive discomfort or alterations in energy levels due to variations in nutrient intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four 1-week diets
This trial's timeline: 3 weeks for screening, Varies for treatment, and four 1-week diets for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Energy Metabolism (kcal per day)
Secondary outcome measures
Meal eating rate (grams per minute)
Meal palatability

Trial Design

4Treatment groups
Experimental Treatment
Group I: 4/ UNF LL, UPF HH, UPF LL, UPF HLExperimental Treatment4 Interventions
Four diets in the order specified
Group II: 3/ UPF LL, UNF LL, UPF HL, UPF HHExperimental Treatment4 Interventions
Four diets in the order specified
Group III: 2/ UPF HL, UPF LL, UPF HH, UNF LLExperimental Treatment4 Interventions
Four diets in the order specified
Group IV: 1/UPF HH, UPF HL, UNF LL, UPF LLExperimental Treatment4 Interventions
Four diets in the order specified

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,314,391 Total Patients Enrolled
446 Trials studying Obesity
588,738 Patients Enrolled for Obesity
Kevin Hall, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
10 Previous Clinical Trials
370 Total Patients Enrolled
6 Trials studying Obesity
314 Patients Enrolled for Obesity

Media Library

Ultra-processed food, both high Clinical Trial Eligibility Overview. Trial Name: NCT05290064 — N/A
Obesity Research Study Groups: 1/UPF HH, UPF HL, UNF LL, UPF LL, 2/ UPF HL, UPF LL, UPF HH, UNF LL, 3/ UPF LL, UNF LL, UPF HL, UPF HH, 4/ UNF LL, UPF HH, UPF LL, UPF HL
Obesity Clinical Trial 2023: Ultra-processed food, both high Highlights & Side Effects. Trial Name: NCT05290064 — N/A
Ultra-processed food, both high 2023 Treatment Timeline for Medical Study. Trial Name: NCT05290064 — N/A

Frequently Asked Questions

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

Are any new volunteers required for this experiment?

"Affirmative. The information present on clinicaltrials.gov affirms that this research is actively recruiting participants, having been initially posted on November 4th 2022 and revised most recently on December 1st 2022. 200 volunteers are sought from a single site for inclusion in the study."

Answered by AI

What type of participant is best suited for this research endeavor?

"This trial seeks 200 obese adults aged 18-60. To qualify, these potential participants must provide a signed and dated informed consent form; pledge to comply with all study protocols, have a stable body weight (less than 5% change in 6 months), BMI of 20 kg/m2 or higher; weigh at least 53 kilograms, participate in stationary cycling sessions with heart rate within the determined parameters without any sign of arrhythmia, and follow lifestyle considerations throughout the course of this experiment."

Answered by AI

To what extent is this trial being utilized by patients?

"Affirmative. Per clinicaltrials.gov, this medical trial is currently searching for qualifying participants and was first listed on November 4th 2022; the latest update to the trial took place on December 1st 2022. The project has a need of 200 subjects across one research centre."

Answered by AI

Are individuals aging over 35 years eligible to join this research project?

"The range of patients that can be enrolled in this trial is from 18 to 60 years old. Meanwhile, there are 212 studies for minors and 626 clinical trials available for seniors aged above 65."

Answered by AI

Who else is applying?

What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~56 spots leftby Dec 2024