Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method
Verified date | January 2019 |
Source | Texas Tech University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Recent epidemiological studies show that egg consumption is associated with insulin resistance and altered glycemic control. For this study, the investigators hypothesize that this association is due to dietary patterns associated with egg consumption, such as saturated fat, and not the consumption of eggs per se. This study will be conducted in two parts that will be conducted simultaneously. Part I will utilize an ecological momentary assessment approach in which dietary patterns associated with egg intake will be determined using an objective measurement of food intake called remote food photography method. In Part II, a randomized partial crossover study will be conducted on the same sample of subjects to test the effects of egg consumption, saturated fat consumption, and consumption of the combination of eggs and saturated fat on glucose, insulin, and hunger and satiety hormone levels.
Status | Completed |
Enrollment | 48 |
Est. completion date | October 3, 2018 |
Est. primary completion date | October 3, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 48 non-diabetic individuals (fasting glucose < 126 mg/dL) - Male or female - BMI from greater or equal to 20 to lesser or equal 60 kg/m2 - Age: 18 - 65 years Exclusion Criteria: - Diabetes - On antidiabetes medication - Pregnant or lactating females - Having a history of gestational diabetes - Having an unstable cardiac condition - Having a major systemic illness - Having a history of drug abuse - Having a history of eating disorders - Having uncontrolled hypothyroidism - Having familial hyperlipidemias - Having allergies sensitivity to or dislike of eggs - Consumption of < 1 egg per week - Attempting to lose weight - On medications that may influence or inhibit appetite, sensory functioning, or hormone signaling- e.g. antibiotics, anti-depressants, obesity medications. Weight loss > 5% in the past 3 months |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University - Department of Nutritional Sciences | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University | American Egg Board, Pennington Biomedical Research Center |
United States,
Djoussé L, Gaziano JM, Buring JE, Lee IM. Egg consumption and risk of type 2 diabetes in men and women. Diabetes Care. 2009 Feb;32(2):295-300. doi: 10.2337/dc08-1271. Epub 2008 Nov 18. — View Citation
Hu FB, Stampfer MJ, Rimm EB, Manson JE, Ascherio A, Colditz GA, Rosner BA, Spiegelman D, Speizer FE, Sacks FM, Hennekens CH, Willett WC. A prospective study of egg consumption and risk of cardiovascular disease in men and women. JAMA. 1999 Apr 21;281(15):1387-94. — View Citation
Martin CK, Correa JB, Han H, Allen HR, Rood JC, Champagne CM, Gunturk BK, Bray GA. Validity of the Remote Food Photography Method (RFPM) for estimating energy and nutrient intake in near real-time. Obesity (Silver Spring). 2012 Apr;20(4):891-9. doi: 10.1038/oby.2011.344. Epub 2011 Dec 1. — View Citation
Shin JY, Xun P, Nakamura Y, He K. Egg consumption in relation to risk of cardiovascular disease and diabetes: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Jul;98(1):146-59. doi: 10.3945/ajcn.112.051318. Epub 2013 May 15. Review. — View Citation
Wallin A, Forouhi NG, Wolk A, Larsson SC. Egg consumption and risk of type 2 diabetes: a prospective study and dose-response meta-analysis. Diabetologia. 2016 Jun;59(6):1204-13. doi: 10.1007/s00125-016-3923-6. Epub 2016 Mar 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference of energy intake (kcal) in meals containing eggs as compared to meals that do not contain eggs | Energy intake will be determined using Remote Food Photography Method (RFPM) and the meals of all test subjects will be categorized based on the presence or the absence of eggs in the meals. | Day 1-7 of the ecological momentary assessment part (Part I) of the study | |
Primary | Difference of energy intake (kcal) in high egg consumers as compared to low egg consumers | Comparison of mean daily energy intake as measured by Remote Food Photography Method (RFPM) between high egg consumers and low egg consumers identified by providing a food frequency questionnaire (FFQ). | Day 1-7 of the ecological momentary assessment part (Part I) of the study | |
Primary | Difference of saturated fat (g) intake in meals containing eggs as compared to meals that do not contain eggs | Saturated fat intake will be determined using Remote Food Photography Method (RFPM) and the meals of all test subjects will be categorized based on the presence or the absence of eggs in the meals. | Day 1-7 of the ecological momentary assessment part (Part I) of the study | |
Primary | Difference of saturated fat (g) intake in high egg consumers as compared to low egg consumers | Comparison of saturated fat intake as measured by Remote Food Photography Method (RFPM) between high egg consumers and low egg consumers identified by providing a food frequency questionnaire (FFQ). | Day 1-7 of the ecological momentary assessment part (Part I) of the study | |
Primary | Difference of blood glucose levels compared between different test breakfasts | This will be measured on visit 1 and 2 after providing test breakfasts. | Changes in concentration (area under the curve; AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study) | |
Primary | Difference of insulin levels compared between different test breakfasts | This will be measured on visit 1 and 2 after providing test breakfasts. | Changes in concentration (area under the curve; AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study) | |
Secondary | Difference of subjective hunger level compared between different test breakfasts | This will be measured on visit 1 and 2 after providing test breakfasts. | Changes in scores (arbitrary units AU) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study) | |
Secondary | Difference of subjective satiety level compared between different test breakfasts | This will be measured on visit 1 and 2 after providing test breakfasts. | Changes in scores (arbitrary units AU) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study) | |
Secondary | Difference of objective hunger compared between different test breakfasts | This will be measured on visit 1 and 2 after providing test breakfasts by measuring serum ghrelin levels. | Changes in concentration (area under the curve AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study) | |
Secondary | Difference of objective satiety compared between different test breakfasts using serum Glucagon-like peptide-1 (GLP-1) levels | This will be measured on visit 1 and 2 after providing test breakfasts by measuring serum GLP-1 levels. | Changes in concentration (area under the curve AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study) | |
Secondary | Difference of objective satiety compared between different test breakfasts using serum Peptide YY (PYY 3-36) levels | This will be measured on visit 1 and 2 after providing test breakfasts by measuring serum PYY 3-36 levels. | Changes in concentration (area under the curve AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study) | |
Secondary | Difference of HbA1c levels in high egg consumers as compared to low egg consumers | This will be measured by taking blood on the visit 1. | Changes in blood concentration (arbitrary units AU) on visit 1 (Part II of the study) | |
Secondary | Difference in Homeostasis Model Assessment-Insulin resistance (HOMA-IR) compared between different test breakfasts | This will be calculated using blood glucose and insulin levels. | Changes in HOMA-IR values (arbitrary units AU) on visit 1 and 2 after providing test breakfasts (Part II of the study) | |
Secondary | Difference in Resting Metabolic Rate (RMR) compared between different test breakfasts | RMR will be assessed following different test breakfasts on visit 1 and 2. | Changes in RMR (kcal/24hrs) on visit 1 and 2 following each test breakfast ( Part II of the study) | |
Secondary | Difference in total energy intake (kcal) compared between Remote Food Photography Method (RFPM), 7-day food record and 24-hour recall | Comparison of mean energy intake as determined by RFPM with mean energy intake determined by 7-day food record and a single 24-hour recall. | Day 1-7 of the ecological momentary assessment part (Part I) of the study |
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