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Protein Pacing for Type 2 Diabetes
N/A
Waitlist Available
Led By Paul J Arciero, PhD
Research Sponsored by Skidmore College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 4 and 8 weeks
Awards & highlights
Study Summary
This trial will study the effects of adding whey protein to the diet of people with pre-diabetes or type 2 diabetes. It will measure changes in glycated hemoglobin (HbA1c) and total body fat.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to whey protein intake such as bloating or gas especially in those with lactose intolerance. Allergic reactions could occur in case of undiagnosed milk protein allergy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 4 and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 4 and 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c
Secondary outcome measures
Change in blood glucose, and lipids
Change in body weight
Change in physical activity
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Protein PacingExperimental Treatment1 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 DietActive Control1 Intervention
The participants in the CON will continue with their usual habitual dietary intake over the 8-week study and receive no intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PP
2005
N/A
~120
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Who is running the clinical trial?
Skidmore CollegeLead Sponsor
18 Previous Clinical Trials
1,040 Total Patients Enrolled
Paul J Arciero, PhDPrincipal InvestigatorSkidmore College
4 Previous Clinical Trials
141 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have emphysema.You have chronic obstructive pulmonary disease (COPD).You have serious heart problems, like blocked arteries or heart failure, or uncontrolled high blood pressure.You have trouble fasting or have low blood sugar levels.You have cancer or are currently receiving treatment for cancer.You do not smoke cigarettes.You have an eating disorder such as anorexia or bulimia.You do not regularly engage in exercise or physical activity.People with pre-diabetes or type 2 diabetes who don't have major heart or metabolic problems according to their medical history and examination by their doctors.You are allergic to milk, sugar alcohols, fructose, or gluten.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Diet
- Group 2: Protein Pacing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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