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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding whey protein to meals can help individuals with pre-diabetes or type 2 diabetes better manage blood sugar and body fat. Participants will either maintain their normal diet or add three servings of whey protein daily for eight weeks. The goal is to determine if the protein lowers blood sugar levels (HbA1c) and body fat. The study seeks non-smoking individuals who are pre-diabetic or have type 2 diabetes and are not very physically active. As an unphased trial, it offers participants the chance to contribute to important research that could enhance diabetes management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that protein pacing is safe for individuals with pre-diabetes or type 2 diabetes?

Research has shown that whey protein, commonly used in protein diets, is generally safe for most people. In studies involving individuals with type 2 diabetes, whey protein did not cause major side effects. Most participants tolerated it well without significant issues.

Some studies suggest a high-protein diet might be linked to a higher risk of developing type 2 diabetes, but no clear evidence indicates that whey protein itself causes this risk. Overall, whey protein is considered safe for people with type 2 diabetes to include in their diets. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about protein pacing for type 2 diabetes because it offers a unique approach compared to standard treatments like insulin therapy or oral medications. Unlike these conventional options, protein pacing involves consuming whey protein at specific times throughout the day, which may help regulate blood sugar levels naturally. This method is intriguing because it emphasizes dietary timing and composition rather than relying solely on pharmaceuticals, potentially offering a more holistic and manageable lifestyle change for individuals with type 2 diabetes.

What evidence suggests that protein pacing might be an effective treatment for type 2 diabetes?

Research has shown that eating protein at certain times during the day, known as protein pacing, might help manage type 2 diabetes by improving insulin use. In this trial, participants in the Protein Pacing group will consume whey protein at specific intervals throughout the day. Studies have found that high-protein diets can lower blood sugar levels, which is important for controlling diabetes. Specifically, adding whey protein to the diet has been linked to better HbA1c levels, a measure of long-term blood sugar control. High-protein diets are also associated with reduced body fat, which can benefit people with type 2 diabetes. Overall, these findings suggest that protein pacing with whey could effectively manage type 2 diabetes symptoms and improve overall health. ^{1 2 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12134278/

Dietary protein and risk of type 2 diabetes - PubMed Central Recent studies have suggested that high-protein diets might improve insulin resistance by altering the levels of metabolic signatures, such as ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05355090

Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics | ... 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 ...

3. uab.edu uab.edu/news/research-innovation/both-high-protein-and-normal-protein-diets-are-effective-for-t2d-management

Both high-protein and normal-protein diets are effective for ... Both a high-protein diet (40 percent of total calories from protein) and a moderate-protein diet (21 percent of total calories from protein) were effective in ...

4. mdpi.com mdpi.com/1422-0067/25/20/10959

Efficacy of a High-Protein Diet to Lower Glycemic Levels in ... In the same way, compared with a DCD, an HPD reduced total glucose AUC by 14% and net glucose AUC by 121%. Insulin also showed improvement with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322004057

High-Protein Diets for Treatment of Type 2 Diabetes Mellitus The objective of this systematic review was to evaluate whether high-protein diets improve glycemic outcomes in people with T2D.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10799123/

Protein intake and type 2 diabetes mellitus: an umbrella ... Higher total protein intake was possibly associated with higher T2D risk, while there is insufficient evidence for a risk increase with higher ...

7. withpower.com withpower.com/trial/phase-type-2-diabetes-mellitus-3-2022-63424

Protein Pacing for Type 2 Diabetes · Info for Participants 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) ...

8. nature.com nature.com/articles/s41598-024-76357-2

Patterns of protein intake and mortality in patients with type ... We aimed to look at the potential relationship between patterns of protein intake and risk of death in adults with type 2 diabetes.