Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by … (NCT03771261) | Clinical Trial Compass
CompletedNot Applicable
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
United States99 participantsStarted 2018-06-15
Plain-language summary
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (with substantial amounts provided from whole eggs and egg whites) with calorie restriction on insulin resistance and weight loss (along with function, body composition, racial disparities, and a number of secondary outcomes) in black and white older adults with prediabetes who are participating in a 4-month intervention. The investigators will compare these effects to the same outcomes with a control group consuming a traditional control regimen of calorie restriction over the same duration.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 60 years
* Identifies as Caucasian/white or African-American/black
* Obese body weight (\>30 kg/m2)
* Able to speak and understand spoken and written English
* Elevated fasting plasma glucose (≥95 and \<126 mg/dL)
* Age-normal Kidney function (≥ 45 mL/min/1.73 m2)
Exclusion Criteria:
* Body weight \> 224 kg (limit of the BodPod)
* Treated or untreated diabetes (prior diagnosis, treatment, or fasting blood glucose ≥126 mg/dL)
* Presence of unstable, acutely symptomatic, or life-limiting illness
* Positive screen for dementia using Mini-Cog evaluation tool
* Neurological conditions causing functional or cognitive impairments
* History of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation)
* Allergy or intolerance to egg products
* Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing, or continuously participate in a randomly assigned lifestyle intervention program for four months
* Inability to walk independently
* Unable to give consent
* Unable to complete written recording forms including journals of eating and exercise behaviors.
* Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications, insulin, metformin or any other hypoglycemic agent
* Primary Care Physician advises against participation
* Smoker
* Unusually or unstable renal function
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline Insulin Resistance at 4 months