Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05355090
• Other study ID #: 2111-1004
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• HbA1c
• Protein Intake
• Type 2 Diabetes

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