Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics

Not Applicable

Active, not recruiting

• Conditions: HbA1c; Protein Intake; Type 2 Diabetes

• Registration Number: NCT05355090
• Lead Sponsor: Skidmore College

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-04-06
• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-05-02
• Primary Completion: 2023-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	0 and 4, and 8 weeks	Quantify changes in HbA1c blood levels vja finger stick of 40ul or venipuncture blood draw of 5ml per visit (weeks 0, 4, and 8)

Secondary Outcome Measures

Name	Time	Method
Change in total body fat and lean body mass	0, 4 and 8 weeks	Quantitative measure of total body fat and muscle mass in kilograms using BODPod (air displacement plethysmography
Change in blood glucose, and lipids	0, 4 and 8 weeks	Finger stick of 40ul or venipuncture blood draw of 5ml per visit (weeks 0, 4, and 8) to quantify changes in mg/dL
Change in body weight	weeks 0, 4, and 8	Quantitative measure of body weight in kilograms using a standard scale
Change in physical activity	0, 4, and 8 weeks	Quantitative measure of physical activity (kilocalories per day) using the ActiGraph accelerometer

Trial Locations

Locations (1)

Human Nutrition and Metabolism Laboratory; 🇺🇸 Saratoga Springs, New York, United States