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Overfeeding for Weight Loss

Phase 2

Waitlist Available

Led By Susi M Votruba, 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 ongoing

Awards & highlights

Study Summary

This trial is investigating how to better predict why some individuals gain or lose weight more easily than others, by examining how the body burns energy over 24 hours with overeating or fasting.

Eligible Conditions

Weight Loss
Obesity
Diet Therapy
Nutrition Therapy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ongoing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ongoing

This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary goal of the current study is to determine if changes in energy expenditure in response to acute over- and underfeeding are related to variation in changes in weight and body energy stores with longer-term over- and underfeeding.

Secondary outcome measures

Determine if hormones, responses to behavioral testing, adipocyte size, body composition, core temperature, spontaneous activity, and food absorption/excretion are related to changes in EE with over/under-feeding and variation in weight change.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Weight LossExperimental Treatment1 Intervention

a weight loss arm in which obese individuals are placed on a 50% decrease from a weight maintenance calorie diet for 6 weeks which (by random assignment) is either a standard 50% decrease in energy intake with all macronutrients held at the same percentage (20% protein, 50% carbohydrate, 30% fat) or a 50% decrease in energy intake with the same absolute protein content (in grams) as the weight maintaining diet while on our clinical research unit then followed as outpatients monthly for 10 months

Group II: OverfeedingExperimental Treatment2 Interventions

an inpatient overfeeding arm in which obesity resistant individuals are prescribed a 150% increase in a weight maintenance calorie diet for 6 weeks which (by random assignment) is either low in protein (6%) content. Overfeeding or Overfeeding Low Pro or with normal (20%) protein content

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Weight Loss

2008

Completed Phase 3

~1460

Overfeeding

2016

Completed Phase 2

~160

Overfeeding Low Pro

2008

Completed Phase 2

~90

Do I qualify?Apply below to find out

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Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,315,211 Total Patients Enrolled

101 Trials studying Weight Loss

18,924 Patients Enrolled for Weight Loss

Susi M Votruba, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4 Previous Clinical Trials

1,355 Total Patients Enrolled

Susanne Votruba, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

3 Previous Clinical Trials

1,259 Total Patients Enrolled

Frequently Asked Questions

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

Are participants aged 20 and over eligible to join this research trial?

"To participate in this trial, prospective patients must be between 18 to 60 years of age. Separately, there are 246 studies available for youngsters aged under 18 and 732 clinical trials targeting individuals over 65."

Answered by AI

Are there any vacant slots available in this trial for participants?

"According to the data on clinicaltrials.gov, enlistment of trial participants has ceased for this experiment which was initially published in May 2008 and revised lastly in November 2022. Notwithstanding, there are currently 1167 other medical trials actively looking for volunteers."

Answered by AI

What criteria must be fulfilled for eligibility in this research initiative?

"This medical trial requires participants to have a dietary regimen and be between 18 and 60 years old. 83 candidates need to join the study in order for it to reach completion."

Answered by AI

Has this therapeutic intervention been given the thumbs up by regulatory authorities?

"Our Power team has evaluated this treatment's safety as a 2, since it is currently in Phase 2 of the clinical trial process and there exists some data attesting to its security but not yet any evidence affirming its efficacy."

Answered by AI