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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.
Previous investigations have demonstrated that simply adding 3 small protein feedings to the normal diet of overweight men and women, independent of caloric restriction and/or engaging in exercise training, significantly reduces body weight, fat mass, abdominal fat, waist circumference, and blood fat (triglyceride) levels (Arciero et al JAP, 2014), and confirms previous research (Baer et al, J Nutr, 2011). This timed ingestion is referred to as protein pacing (PP) and has been utilized in numerous scientific investigations with a great deal of success by the PI (see references). This one, simple, dietary modification, independent of reducing calorie intake and/or engaging in exercise training, is noteworthy and exceptional in terms of health improvements derived from diet alone. Unfortunately, the incidence and healthcare costs associated with type 2 diabetes mellitus (T2DM) are overwhelming. Currently, more than 34 million Americans have T2DM (1 in 10) and is increasing at alarming rates (>4.0%/year) among all segments of the population. Equally disturbing, T2DM costs the US more than $330 billion a year, including $237 billion in direct medical costs and $90 billion in reduced worker productivity. Thus, identifying evidence-based, effective, time-efficient, and easy-to-follow lifestyle strategies are vital to reducing these staggering healthcare costs and improving the health of T2DM patients. Indeed, lifestyle therapies remain the most effective treatments for T2DM outcomes.
The purpose of this study is to 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein Pacing | Experimental | During the 8 week trial, the Protein Pacing (PP) group will consume 3 daily servings of whey protein powder mixed with water at timed intervals: morning (0600-0800), afternoon (1000-1400), and evening (2000-2200) in addition to their normal food intake. |
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| Standard Diet | No Intervention | The participants in the CON will continue with their usual habitual dietary intake over the 8-week study and receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PP | Dietary Supplement | Protein Pacing three times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in blood glucose, and lipids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Arciero, PhD | Skidmore College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition and Metabolism Laboratory | Saratoga Springs | New York | 12866 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27483317 | Background | 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. | |
| 24833780 | Background |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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24 volunteers with pre-diabetes or Type 2 diabetes mellitus (n=24) will be quasi-randomized to one of the two groups matched by sex (men/women) and body weight. Participants will be enrolled in the study as a single cohort and participate in a 8-week protein supplementation regimen consisting of three daily servings of whey protein along with their typical dietary intake.
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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 |
| Change in physical activity | Quantitative measure of physical activity (kilocalories per day) using the ActiGraph accelerometer | 0, 4, and 8 weeks |
| Change in body weight | Quantitative measure of body weight in kilograms using a standard scale | weeks 0, 4, and 8 |
| 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. |
| 23703835 | Background | 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. |
| D004700 | Endocrine System Diseases |