Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics

NCT05355090 | Active Not Recruiting

• 1 other identifier: 2111-1004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; HbA1c; Protein Intake

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in total body fat and lean body mass

  0, 4 and 8 weeks

• Change in blood glucose, and lipids

  0, 4 and 8 weeks

• Change in physical activity

  0, 4, and 8 weeks

• Change in body weight

  weeks 0, 4, and 8

Study Arms (2)

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.

Dietary Supplement: PP

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.

Interventions

PP DIETARY_SUPPLEMENT

Protein Pacing three times per day

Protein Pacing

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skidmore College: lead

Study Sites (1)

Human Nutrition and Metabolism Laboratory

Saratoga Springs, New York, 12866, United States

Location

Related Publications (3)

• 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.

  PMID: 27483317 BACKGROUND

• 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.

  PMID: 24833780 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.

  PMID: 23703835 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Paul J Arciero, PhD

  Skidmore College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 2, 2022
• Study Start: April 6, 2022
• Primary Completion: April 1, 2023
• Study Completion: December 31, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)