Pre DiabetesEGGSPDITeNCT03771261
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
A study testing Weight Loss and Egg Protein in people with Pre Diabetes and Obesity, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pre Diabetes, Obesity
- What is being tested?
- Weight Loss and Egg Protein
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 8 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the detailed description
Older (>60 yrs) men and women (50% African American, 50% white) who are obese (BMI >30 kg/m2) and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to one to two treatment groups: 1) Weight loss intervention (WL-Control; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d; and 2) High protein weight loss intervention (WL-Protein; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein (> 30g protein, 3/day, 60-70% egg protein). Primary (insulin resistance/sensitivity, weight loss) and secondary outcomes (physical function, body composition, diet adherence, cognitive function, readiness to change) will be measured at 0 and 4 months.
- Conditions
- Pre Diabetes, Obesity
- Being tested
- Weight Loss, Egg Protein
- Keywords
- Egg, Protein, Aging, Health Disparities, Weight Loss
- Medical subject headings
- Glucose Intolerance, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight LossBehavioural
Participants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings.
Egg ProteinDietary supplement
Participants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder.
| Study group | Role | What they receive |
|---|---|---|
| WL-Control | Placebo comparator | Weight loss intervention (WL-Control; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d. Receives: Behavioral: Weight Loss |
| WL-Protein | Active comparator | High-protein weight loss intervention (WL-Protein; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from eggs or egg protein powder that will be provided to WL-Protein participants. Receives: Behavioral: Weight Loss; Dietary Supplement: Egg Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Insulin Resistance at 4 months
Blood glucose and insulin levels in whole blood will be used to compute HOMA-IR (= glucose mg/dL x insulin mg/dL/405)
Measured: 0 to 4 months
Change from Baseline Body weight at 4 months
Weight loss as measured in light clothing on a dedicated scale.
Measured: 0 to 4 months
Secondary outcomes (22)
Change from baseline Short Physical Performance Battery at 4 months
Physical Performance as measured by Short Physical Performance Battery (SPPB)
Measured: 0 to 4 months
Change from baseline 6-minute walk (meters) at 4 months
Distance (meters) walked in 6 minutes
Measured: 0 to 4 months
Change from baseline 8-foot up and Go time at 4 months
Time it takes to get up from a chair walk around a cone and sit back down (8-foot up and go)
Measured: 0 to 4 months
Change from baseline 30-second chair stands (number of stands) at 4 months
the number of chair stands completed in 30 seconds
Measured: 0 to 4 months
Change from baseline handgrip strength at 4 months
the highest weight achieved from 2 attempts using the JAMAR dynamometer
Measured: 0 to 4 months
Change from baseline grooved pegboard time at 4 months
measure of hand dexterity, time it takes to fit pegs into grooved pegboard
Measured: 0 to 4 months
Change from baseline fat mass (%) at 4 months
Body fat mass (%) as measured by Bodpod
Measured: 0 to 4 months
Change from baseline fat mass (kgs) at 4 months
Body fat mass (kg) as measured by Bodpod
Measured: 0 to 4 months
Change from baseline lean mass (kgs) at 4 months
Body lean mass (kg) as measured by Bodpod
Measured: 0 to 4 months
Change from baseline lean mass (%) at 4 months
Body lean mass (%) as measured by Bodpod
Measured: 0 to 4 months
Change from baseline minimal waist circumference at 4 months
Body proportions will be measured at the minimal waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Measured: 0 to 4 months
Change from baseline umbilical waist circumference at 4 months
Body proportions will be measured at the umbilical waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Measured: 0 to 4 months
Change from baseline hip circumference at 4 months
Body proportions will be measured at the hip using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Measured: 0 to 4 months
Change from baseline total calories at 4 months
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Measured: 0 to 4 months
Change from baseline macronutrient intake at 4 months
Macronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)
Measured: 0 to 4 months
Change from baseline micronutrient intake at 4 months
Micronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)
Measured: 0 to 4 months
Change from baseline Symbol digit modalities test at 4 months
Symbol Digit Modalities Test measures cognitive impairment
Measured: 0 to 4 months
Change from baseline Trail Making Test at 4 months
Trail Making Test neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
Measured: 0 to 4 months
Change from baseline Hopkins Verbal Learning Test at 4 months
Hopkins Verbal Learning Test consists of three trials of free-recall of a 12-item, semantically categorized list, followed by yes/no recognition.
Measured: 0 to 4 months
Change from baseline Profile of Mood States at 4 months
Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".
Measured: 0 to 4 months
Change from baseline Perceived Stress Scale at 4 months
Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: 0 to 4 months
Change from Baseline Insulin Sensitivity at 4 months
insulin sensitivity HOMA-β (= 360 x insulin mg/dL / glucose mg/dL - 63; %).
Measured: 0 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start15 Jun 2018
- Primary completion5 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Sponsor
- Investigators
- Connie Bales, RD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771261
- Sponsor's protocol ID
- Pro00089075
- Acronym
- EGGSPDITe
- Status last verified
- Jan 2022
- First submitted
- 21 Nov 2018
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porter Starr KN, McDonald SR, Bales CW. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials. J Am Med Dir Assoc. 2014 Apr;15(4):240-50. doi: 10.1016/j.jamda.2013.11.008. Epub 2014 Jan 17.
PubMed 24445063Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.
PubMed 26786203Porter Starr KN, McDonald SR, Weidner JA, Bales CW. Challenges in the Management of Geriatric Obesity in High Risk Populations. Nutrients. 2016 May 4;8(5):262. doi: 10.3390/nu8050262.
PubMed 27153084
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
- ClinicalTrials.gov ID
- NCT03771261
- Acronym / sponsor ID
- EGGSPDITe / Pro00089075
- Conditions
- Pre Diabetes, Obesity
- Keywords
- Egg, Protein, Aging, Health Disparities, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Older (>60 yrs) men and women (50% African American, 50% white) who are obese (BMI >30 kg/m2) and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to one to two treatment groups: 1) Weight loss intervention (WL-Control; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d; and 2) High protein weight loss intervention (WL-Protein; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein (> 30g protein, 3/day, 60-70% egg protein). Primary (insulin resistance/sensitivity, weight loss) and secondary outcomes (physical function, body composition, diet adherence, cognitive function, readiness to change) will be measured at 0 and 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WL-Control | Placebo comparator | Behavioral: Weight LossWeight loss intervention (WL-Control; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d. |
| WL-Protein | Active comparator | Behavioral: Weight Loss, Dietary Supplement: Egg ProteinHigh-protein weight loss intervention (WL-Protein; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from eggs or egg protein powder that will be provided to WL-Protein participants. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight LossParticipants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings. | Behavioural | WL-Control, WL-Protein |
| Egg ProteinParticipants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder. | Dietary supplement | WL-Protein |
Primary outcome
Change from Baseline Insulin Resistance at 4 months
Time frame: 0 to 4 months
Blood glucose and insulin levels in whole blood will be used to compute HOMA-IR (= glucose mg/dL x insulin mg/dL/405)
Change from Baseline Body weight at 4 months
Time frame: 0 to 4 months
Weight loss as measured in light clothing on a dedicated scale.
22 secondary outcomes
Change from baseline Short Physical Performance Battery at 4 months
Time frame: 0 to 4 months
Change from baseline 6-minute walk (meters) at 4 months
Time frame: 0 to 4 months
Change from baseline 8-foot up and Go time at 4 months
Time frame: 0 to 4 months
Change from baseline 30-second chair stands (number of stands) at 4 months
Time frame: 0 to 4 months
Change from baseline handgrip strength at 4 months
Time frame: 0 to 4 months
Change from baseline grooved pegboard time at 4 months
Time frame: 0 to 4 months
Change from baseline fat mass (%) at 4 months
Time frame: 0 to 4 months
Change from baseline fat mass (kgs) at 4 months
Time frame: 0 to 4 months
Change from baseline lean mass (kgs) at 4 months
Time frame: 0 to 4 months
Change from baseline lean mass (%) at 4 months
Time frame: 0 to 4 months
Change from baseline minimal waist circumference at 4 months
Time frame: 0 to 4 months
Change from baseline umbilical waist circumference at 4 months
Time frame: 0 to 4 months
Change from baseline hip circumference at 4 months
Time frame: 0 to 4 months
Change from baseline total calories at 4 months
Time frame: 0 to 4 months
Change from baseline macronutrient intake at 4 months
Time frame: 0 to 4 months
Change from baseline micronutrient intake at 4 months
Time frame: 0 to 4 months
Change from baseline Symbol digit modalities test at 4 months
Time frame: 0 to 4 months
Change from baseline Trail Making Test at 4 months
Time frame: 0 to 4 months
Change from baseline Hopkins Verbal Learning Test at 4 months
Time frame: 0 to 4 months
Change from baseline Profile of Mood States at 4 months
Time frame: 0 to 4 months
Change from baseline Perceived Stress Scale at 4 months
Time frame: 0 to 4 months
Change from Baseline Insulin Sensitivity at 4 months
Time frame: 0 to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 24445063Porter Starr KN, McDonald SR, Bales CW. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials. J Am Med Dir Assoc. 2014 Apr;15(4):240-50. doi: 10.1016/j.jamda.2013.11.008. Epub 2014 Jan 17.
- Background: PubMed 26786203Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.
- Background: PubMed 27153084Porter Starr KN, McDonald SR, Weidner JA, Bales CW. Challenges in the Management of Geriatric Obesity in High Risk Populations. Nutrients. 2016 May 4;8(5):262. doi: 10.3390/nu8050262.
- Duke University School of MedicineLink provided by the sponsor.
- Egg Nutrition CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Bales, RD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss and Egg Protein in people with Pre Diabetes and Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Insulin Resistance at 4 months (time frame: 0 to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03771261, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.