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Behavioural Intervention

low-fat diet then low-carbohydrate diet for Obesity

N/A
Waitlist Available
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 8 weeks
Awards & highlights

Study Summary

"This trial aims to study the effects of the order in which people receive a low-fat or low-carbohydrate diet over 8 weeks. Participants will live at home but have 3 visits to the

Who is the study for?
This trial is for adults aged 19 to 50 with a BMI of 25 or higher. Participants will follow and switch between low-fat and low-carb diets over an 8-week period, all while living at home. They must be willing to visit the NIH three times, track their weight daily, monitor physical activity and glucose levels, and attend virtual meetings.Check my eligibility
What is being tested?
The study tests whether starting with a low-carbohydrate diet leads to greater body fat loss compared to starting with a low-fat diet when each is followed for four weeks at home. Meals are provided, and participants' metabolism, bone density, muscle mass, body fat, and various health markers are monitored.See study design
What are the potential side effects?
Potential side effects may include changes in energy levels due to dietary adjustments. Low-carb diets might cause 'keto flu,' including headache, fatigue or irritability initially. Low-fat diets could lead to hunger or dissatisfaction if not used to such eating patterns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in total fat mass
Secondary outcome measures
Rate of body weight change during low-carbohydrate diet
Rate of body weight change during low-fat diet
Rate of body weight change from baseline to week 8

Trial Design

2Treatment groups
Experimental Treatment
Group I: low-fat diet then low-carbohydrate dietExperimental Treatment2 Interventions
A low-fat followed by low-carbohydrate diet, each lasting for 4 weeks in adults with overweight or obesity
Group II: low-carbohydrate diet then low-fat dietExperimental Treatment2 Interventions
A low-carbohydrate followed by low-fat diet, each lasting for 4 weeks in adults with overweight or obesity

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,364 Previous Clinical Trials
4,315,302 Total Patients Enrolled
447 Trials studying Obesity
588,886 Patients Enrolled for Obesity
Kevin Hall, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
10 Previous Clinical Trials
470 Total Patients Enrolled
6 Trials studying Obesity
414 Patients Enrolled for Obesity

Frequently Asked Questions

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

Are individuals currently able to apply and participate in this ongoing clinical trial?

"Per clinicaltrials.gov, the current phase of this medical study does not involve participant recruitment. Initially shared on 3/27/2024 and last revised on 3/21/2024, it is currently inactive for enrollment. Nonetheless, there are over a thousand trials available seeking participants at present."

Answered by AI

Is there an age limit for potential participants in this medical study, specifically with respect to individuals below the age of 75?

"Prospective participants must be at least 18 years old but no older than 50 to meet the age requirements for this research study."

Answered by AI

What are the preferred criteria for individuals who can take part in this research study?

"Individuals meeting the criteria of being between 18 and 50 years old with a diagnosis of obesity are eligible to participate in this study. The trial has capacity for up to 100 participants."

Answered by AI
Recent research and studies
Nature MedicineJournal
Effect of a Plant-based, Low-fat Diet Versus an Animal-based, Ketogenic Diet on Ad Libitum Energy Intake
Hall, Kevin D., Juen Guo, Amber B. Courville, James Boring, Robert Brychta, Kong Y. Chen, Valerie Darcey, et al.. 2021. “Effect of a Plant-based, Low-fat Diet Versus an Animal-based, Ketogenic Diet on Ad Libitum Energy Intake”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-020-01209-1.
clinicaltrials.govStudy
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
2024. "Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06325722.
All > Overweight
~67 spots leftby Jul 2026
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