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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05355090
Other study ID # 2111-1004
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 6, 2022
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Skidmore College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Dietary Supplement:
PP
Protein Pacing three times per day

Locations

Country Name City State
United States Human Nutrition and Metabolism Laboratory Saratoga Springs New York

Sponsors (1)

Lead Sponsor Collaborator
Skidmore College

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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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