Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics

Skidmore College

Status: Active, not recruiting

Conditions: Protein Intake; HbA1c; Type 2 Diabetes

Treatments: Dietary Supplement: PP

Study type: Interventional

Funder types: Other

Identifiers

NCT05355090

2111-1004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Protein Pacing

Experimental group

Description:

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.

Treatment:

Dietary Supplement: PP

Standard Diet

No Intervention group

Description:

The participants in the CON will continue with their usual habitual dietary intake over the 8-week study and receive no intervention.