Protein Pacing for Type 2 Diabetes

Overseen By Paul J Arciero, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Skidmore College

Disqualifiers: Emphysema, Heart disease, COPD, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Paul J Arciero, PhD

Principal Investigator

Skidmore College

Are You a Good Fit for This Trial?

This trial is for men and women with pre-diabetes or type 2 diabetes who have been weight stable, are non-smokers, and lead a sedentary to lightly active lifestyle. They should not have significant cardiovascular or metabolic diseases. People with emphysema, COPD, severe heart disease, fasting intolerances, cancer, allergies to milk products or certain sugars, or eating disorders cannot participate.

Inclusion Criteria

Weight stable (+/-2kg) for at least 6 months prior to beginning the study

You do not smoke cigarettes.

You do not regularly engage in exercise or physical activity.

Exclusion Criteria

You have emphysema.

You have chronic obstructive pulmonary disease (COPD).

Pregnant women or those looking to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 daily servings of whey protein powder mixed with water at timed intervals for 8 weeks

8 weeks

3 visits (in-person) at weeks 0, 4, and 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Protein Pacing

Trial Overview The study tests the effects of adding whey protein supplements three times daily to the regular diet of participants over eight weeks. It aims to measure how this regimen affects blood sugar control (HbA1c levels) and body fat in individuals with pre-diabetes or type 2 diabetes.

How Is the Trial Designed?

Group I: Protein Pacing Experimental Treatment 1 Intervention

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.

Group II: Standard Diet Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Skidmore College

Lead Sponsor

Trials

20

Recruited

1,100+