Type 2 Diabetes Clinical Trial
Official title:
Effects of Daily Protein Supplementation for 8 Weeks on Improved Glucose, Insulin, and HbA1c Levels in Pre-Diabetics or Type 2 Diabetes Mellitus
Verified date | April 2024 |
Source | Skidmore College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine the effects of protein (whey) supplementation added to the normal diet of pre-diabetes or diagnosed type 2 diabetes mellitus (T2DM) men and women on plasma glycated hemoglobin (HbA1c) and total body fat levels. Specifically, this study will directly quantify the impact of 3x/day timed ingestion of supplemental whey protein (20 grams of 80 calories per serving) added to the normal diet of free-living pre-diabetic or T2DM men and women over an 8-week study period on the major diagnostic outcome of pre-diabetic and T2DM (HbA1c levels) and total body fat levels. This study will quantify changes in HbA1C and total body fat levels in 24 pre-diabetics or T2DM participants.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | December 31, 2024 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: - non-smoker - weight stable (+/-2kg) for at least 6 months prior to beginning the study - Pre-diabetic and Type 2 diabetic mellitus men and women with no known significant cardiovascular or metabolic diseases as assessed by a medical history and a comprehensive medical examination by their physicians - Sedentary or lightly active (<30 min, 2d/wk of structured physical activity) as assessed by a Physical Activity questionnaire Exclusion Criteria: - Emphysema - Significant heart disease (CABG, CHF, VFib, Hypercholesterolemia, Uncontrolled High Blood Pressure, etc.) - COPD - Cancer or undergoing treatment for cancer - Allergies to milk or milk products, sugar alcohols, fructose, or gluten - Anorexia or Bulimia - Fasting intolerances/hypoglycemia - pregnant women or those looking to become pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Human Nutrition and Metabolism Laboratory | Saratoga Springs | New York |
Lead Sponsor | Collaborator |
---|---|
Skidmore College |
United States,
Arciero PJ, Baur D, Connelly S, Ormsbee MJ. Timed-daily ingestion of whey protein and exercise training reduces visceral adipose tissue mass and improves insulin resistance: the PRISE study. J Appl Physiol (1985). 2014 Jul 1;117(1):1-10. doi: 10.1152/japplphysiol.00152.2014. Epub 2014 May 15. — View Citation
Arciero PJ, Edmonds R, He F, Ward E, Gumpricht E, Mohr A, Ormsbee MJ, Astrup A. Protein-Pacing Caloric-Restriction Enhances Body Composition Similarly in Obese Men and Women during Weight Loss and Sustains Efficacy during Long-Term Weight Maintenance. Nutrients. 2016 Jul 30;8(8):476. doi: 10.3390/nu8080476. — View Citation
Arciero PJ, Ormsbee MJ, Gentile CL, Nindl BC, Brestoff JR, Ruby M. Increased protein intake and meal frequency reduces abdominal fat during energy balance and energy deficit. Obesity (Silver Spring). 2013 Jul;21(7):1357-66. doi: 10.1002/oby.20296. Epub 2013 May 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c | Quantify changes in HbA1c blood levels vja finger stick of 40ul or venipuncture blood draw of 5ml per visit (weeks 0, 4, and 8) | 0 and 4, and 8 weeks | |
Secondary | Change in total body fat and lean body mass | Quantitative measure of total body fat and muscle mass in kilograms using BODPod (air displacement plethysmography | 0, 4 and 8 weeks | |
Secondary | Change in blood glucose, and lipids | Finger stick of 40ul or venipuncture blood draw of 5ml per visit (weeks 0, 4, and 8) to quantify changes in mg/dL | 0, 4 and 8 weeks | |
Secondary | Change in physical activity | Quantitative measure of physical activity (kilocalories per day) using the ActiGraph accelerometer | 0, 4, and 8 weeks | |
Secondary | Change in body weight | Quantitative measure of body weight in kilograms using a standard scale | weeks 0, 4, and 8 |
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