Diabetes Mellitus, Type 2NCT03272074
Egg Consumption and Glycemic Control in Individuals With Pre- and Type II-diabetes
A study testing Egg and egg white in people with Diabetes Mellitus, Type 2 and Obesity, run by Florida State University at 1 site in United States.
Trial summary
The intent of this study is to examine the extent to which daily incorporation of egg into a diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetes. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Pre Diabetes
- What is being tested?
- Egg and egg white
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2015to 5 Aug 2017
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight and obese, BMI is between 25 kg/m2 and 45 kg/m2
- With pre- and type II-diabetes. Subjects will be eligible if their Hgb A1c level is >5.6%
Who cannot join
- Subjects with BMI≤ 24 or ≥46 kg/m2
- Uncontrolled hypertension (≥160/100 mmHg), active cancer, asthma, thyroid, glaucoma, kidney, liver and pancreatic diseases will be excluded from the study.
- Subjects who are participating in any weight loss program and/or are heavy smokers (more than 20 cigarettes per day) will be excluded from the study.
- Subjects who are allergic to egg and egg products will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Egg Consumption Positively Affects Glycemic Control and Insulin Sensitivity in Individuals With Pre- and Type II-diabetes
The intent of this study is to examine the extent to which daily incorporation of egg into a diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is that the daily incorporation of one large egg into a diet for 12 weeks will exert positive effects on factors associated with glycemic control and insulin sensitivity in overweight and obese adults with pre- and type II-diabetes through improvements in body weight, body composition, and lipid metabolism.
Read the detailed description
Pre-diabetes is a condition that is characterized by elevated fasting blood glucose levels secondary to insulin resistance; however, fasting blood glucose levels are not elevated to the extent where it can be classified as type II-diabetes. Pre-diabetes may lead to type II-diabetes and is estimated to do so at an annual rate of approximately 10% in the United States (US) where approximately 79 million individuals have been diagnosed with pre-diabetes. In addition, most of the individuals presenting with pre-diabetes are overweight or obese, which makes long-term weight management an essential component in reducing the development of diabetes. Eggs are a rich source of important nutrients such as vitamins, minerals, proteins, carotenoids, choline, and lecithin. Many of the nutrients found in eggs function as antioxidants or as an essential component of antioxidants. Several studies have demonstrated that the onset and progression of diabetes are associated with increased oxidative stress. In vitro studies have shown that high-density lipoprotein (HDL) acts as a buffer mechanism for oxidative stress and inflammation due to its antioxidant effects. Thus, high blood levels of HDL may reduce insulin resistance and subsequently the development of type II-diabetes through its antioxidant and anti-inflammatory effects. Additionally, HDL can exert beneficial effects on glucose levels through the apolipoprotein A-1 (Apo A) action which increases glucose uptake by increasing insulin secretion in pancreatic beta cells. Because the development of diabetes involves an interaction between genetic predisposition and environmental factors including and excessive body weight, and eggs have been shown to positively influence body composition, we believe that eggs can improve glycemic control, insulin sensitivity, and lipid profiles through improvements in weight and body composition. To our knowledge, there have not been any studies investigating the effects of dietary egg consumption on improving glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetics. Our long-term goal is to bring forth evidence that the regular consumption of eggs is effective in reducing insulin resistance and subsequently the incidence of pre-diabetes and type II-diabetes.
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Pre Diabetes
- Being tested
- Egg and egg white
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg and egg whiteOther
Participants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities.
| Study group | Role | What they receive |
|---|---|---|
| Egg Group (Group A) | Experimental | Participants will consume one large egg per day for 12 weeks Receives: Other: Egg and egg white |
| Egg White Group (Group B) | Active comparator | Participants will consume equivalent amounts of egg whites for 12 weeks Receives: Other: Egg and egg white |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose, insulin resistance, and insulin sensitivity
Commercially available enzyme-linked immunosorbent assay (ELISA) kits will be used to measure fasting blood glucose levels (mg/dL.). Insulin levels will be measured using a commercially available ELISA kit (mg/dL). blood glucose and insulin level measurements will be used to calculate Insulin sensitivity and insulin resistance will be measured using HOMA-IR and HOMA-β using the HOMA2 Calculator v2.2.2
Measured: 12 weeks
Secondary outcomes (1)
Lipid panel
ELISA kits will be used to measure the lipid panel parameters (mg/dL)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start11 Sep 2015
- Primary completion7 Sep 2016
- Study completion5 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Florida State 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Principal investigator, Bahram Arjmandi, Florida State University
- Investigators
- Shirin Pourafshar, PhD, Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272074
- Sponsor's protocol ID
- 2015.15638
- Other IDs
- 2015
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egg Consumption Positively Affects Glycemic Control and Insulin Sensitivity in Individuals With Pre- and Type II-diabetes
- ClinicalTrials.gov ID
- NCT03272074
- Acronym / sponsor ID
- 2015.15638
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- 11 Sep 2015 (actual)
- Primary completion
- 7 Sep 2016 (actual)
- Study completion
- 5 Aug 2017 (actual)
- First posted
- 5 Sep 2017 (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 intent of this study is to examine the extent to which daily incorporation of egg into a diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is that the daily incorporation of one large egg into a diet for 12 weeks will exert positive effects on factors associated with glycemic control and insulin sensitivity in overweight and obese adults with pre- and type II-diabetes through improvements in body weight, body composition, and lipid metabolism.
Detailed description
Pre-diabetes is a condition that is characterized by elevated fasting blood glucose levels secondary to insulin resistance; however, fasting blood glucose levels are not elevated to the extent where it can be classified as type II-diabetes. Pre-diabetes may lead to type II-diabetes and is estimated to do so at an annual rate of approximately 10% in the United States (US) where approximately 79 million individuals have been diagnosed with pre-diabetes. In addition, most of the individuals presenting with pre-diabetes are overweight or obese, which makes long-term weight management an essential component in reducing the development of diabetes. Eggs are a rich source of important nutrients such as vitamins, minerals, proteins, carotenoids, choline, and lecithin. Many of the nutrients found in eggs function as antioxidants or as an essential component of antioxidants. Several studies have demonstrated that the onset and progression of diabetes are associated with increased oxidative stress. In vitro studies have shown that high-density lipoprotein (HDL) acts as a buffer mechanism for oxidative stress and inflammation due to its antioxidant effects. Thus, high blood levels of HDL may reduce insulin resistance and subsequently the development of type II-diabetes through its antioxidant and anti-inflammatory effects. Additionally, HDL can exert beneficial effects on glucose levels through the apolipoprotein A-1 (Apo A) action which increases glucose uptake by increasing insulin secretion in pancreatic beta cells. Because the development of diabetes involves an interaction between genetic predisposition and environmental factors including and excessive body weight, and eggs have been shown to positively influence body composition, we believe that eggs can improve glycemic control, insulin sensitivity, and lipid profiles through improvements in weight and body composition. To our knowledge, there have not been any studies investigating the effects of dietary egg consumption on improving glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetics. Our long-term goal is to bring forth evidence that the regular consumption of eggs is effective in reducing insulin resistance and subsequently the incidence of pre-diabetes and type II-diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egg Group (Group A) | Experimental | Other: Egg and egg whiteParticipants will consume one large egg per day for 12 weeks |
| Egg White Group (Group B) | Active comparator | Other: Egg and egg whiteParticipants will consume equivalent amounts of egg whites for 12 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight and obese, BMI is between 25 kg/m2 and 45 kg/m2
- With pre- and type II-diabetes. Subjects will be eligible if their Hgb A1c level is >5.6%
Key exclusion criteria (4 listed)
- Subjects with BMI≤ 24 or ≥46 kg/m2
- Uncontrolled hypertension (≥160/100 mmHg), active cancer, asthma, thyroid, glaucoma, kidney, liver and pancreatic diseases will be excluded from the study.
- Subjects who are participating in any weight loss program and/or are heavy smokers (more than 20 cigarettes per day) will be excluded from the study.
- Subjects who are allergic to egg and egg products will also be excluded from the study.
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 |
|---|---|---|
| Egg and egg whiteParticipants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities. | Other | Egg Group (Group A), Egg White Group (Group B) |
Primary outcome
Fasting blood glucose, insulin resistance, and insulin sensitivity
Time frame: 12 weeks
Commercially available enzyme-linked immunosorbent assay (ELISA) kits will be used to measure fasting blood glucose levels (mg/dL.). Insulin levels will be measured using a commercially available ELISA kit (mg/dL). blood glucose and insulin level measurements will be used to calculate Insulin sensitivity and insulin resistance will be measured using HOMA-IR and HOMA-β using the HOMA2 Calculator v2.2.2
1 secondary outcome
Lipid panel
Time frame: 12 weeks
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 5 Sep 2017.
- 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.
Shirin Pourafshar, PhD study director
Florida State 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 Egg and egg white in people with Diabetes Mellitus, Type 2 and Obesity, run by Florida State 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 2 inclusion and 4 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 5 Sep 2017. 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. 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?
Fasting blood glucose, insulin resistance, and insulin sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2017.