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Protein Intake Patterns for Obesity Management
N/A
Waitlist Available
Led By Shanon Casperson, PhD
Research Sponsored by USDA Grand Forks Human Nutrition Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Free of any major illness/disease
Females of childbearing age must be on birth control for a minimum of 3 months prior to study start and have regular menstrual cycles
Must not have
Unable or unwilling to consume animal products
Have the presence of acute illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours after meal consumption
Awards & highlights
No Placebo-Only Group
Summary
This trial will see if changing when you eat protein affects how your body uses food for energy, and if it reduces snack cravings.
Who is the study for?
This trial is for adults with a BMI < 25 or between 30-34.5, who are generally healthy and have not had significant weight changes recently. Women of childbearing age must use birth control and have regular cycles. Participants should eat normal amounts of protein and maintain consistent activity levels.
What is being tested?
The study investigates how the timing of protein intake affects energy metabolism and the desire to snack. It compares two patterns: even distribution of protein throughout the day versus a high-protein breakfast with less at other meals.
What are the potential side effects?
Since this trial involves dietary adjustments rather than medication, side effects may include changes in digestion or appetite but are expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any major illnesses.
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I have been on birth control for at least 3 months and have regular periods.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not eat or use animal products.
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I am currently experiencing a sudden illness.
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I have a metabolic disease.
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My high blood pressure is not under control.
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I have an infectious disease.
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I have had cancer in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 hours after meal consumption
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours after meal consumption
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fat, carbohydrate, and protein utilization
Relative reinforcing value (RRV) of energy-dense snack foods
Secondary study objectives
Peripheral neurotransmitter metabolites
Psychoactive Effect Questionnaire
Satiety visual analog scales
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Skewed proteinExperimental Treatment1 Intervention
Menu to provide 90 g of protein per day in a skewed distribution of 10 g at breakfast, 15 g at lunch and 65 g at dinner.
Group II: Even proteinExperimental Treatment1 Intervention
Menu to provide 90 g of protein per day in an even distribution of 30 g at each meal.
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Who is running the clinical trial?
USDA Grand Forks Human Nutrition Research CenterLead Sponsor
58 Previous Clinical Trials
5,251 Total Patients Enrolled
22 Trials studying Obesity
1,059 Patients Enrolled for Obesity
Shanon Casperson, PhDPrincipal Investigator - USDA Grand Forks Human Nutrition Research Center
USDA Grand Forks Human Nutrition Research Center
9 Previous Clinical Trials
209 Total Patients Enrolled
4 Trials studying Obesity
87 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication that affects my energy levels or appetite.I do not eat or use animal products.I am currently experiencing a sudden illness.I can arrange my own travel to the Center.I have a metabolic disease.My high blood pressure is not under control.I do not have any major illnesses.I have an infectious disease.I have been on birth control for at least 3 months and have regular periods.I have had cancer in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Even protein
- Group 2: Skewed protein
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.