Back to resultsCasinomacropeptide and Satiety (CMP2)
Primary Purpose
Lack of Satiety, Excess Intake of Macronutrients, Appetite Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey
Whey-CMP
Control
CMP
MPI
CPI
Sponsored by
About this trial
This is an interventional basic science trial for Lack of Satiety focused on measuring Satiety, Food intake regulation, Appetite regulation, Dairy Protein
Eligibility Criteria
Inclusion Criteria:
- Healthy
- Unrestrained (score ≤ 10 on the Eating Inventory (EI) questionnaire, Stunkard and Messick 1985)
- Women
- 18 years of age
- Consume a low/moderate protein diet (12-20% protein energy).
- Meet BMI criteria of 19 to 24 kg/m2 OR 29 to 34 kg/m2, inclusive.
Exclusion Criteria:
- Women who score ≥ 10 on the Beck Depression Inventory (BDI, Beck and Beamesdorfer 1974)
- Women who score ≥ 30 on Eating Attitudes Test (EAT, Garner and Garfinkel 1979),
- Have current or past (previous 1 year) medical conditions that may interfere with any of the outcomes of this study.
- Weigh less than 110 lbs
- Are currently or have been modifying diet or exercise patterns to gain or lose weight in previous 60 days
- Have unstable body weight (fluctuations of ≥ 5 kg in 60 day period)
- Are excessive exercisers or trained athletes
- Taking any medications that would affect appetite or any other study-described endpoint will also be excluded.
- Allergies or intolerances to foods consumed in the study.
- Smoker
- Pregnant/lactation
Sites / Locations
- University of California, Davis (Ragle Human Nutrition Research Center)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Whey protein
Whey-CMP
Control
CMP (casinomacropeptide)
MPI
CPI (casein)
Arm Description
Complete whey protein.
Complete whey protein missing the CMP (aka GMP) portion of the peptide.
Placebo preload control, matched for energy.
Small peptide cleaved from complete whey protein.
Complete milk protein.
Preload containing casein.
Outcomes
Primary Outcome Measures
Post-prandial satiety
Blood biochemical markers of appetite regulation.
Post-prandial satiety
Assessing biobehavioral aspects of appetite regulation through VAS.
Secondary Outcome Measures
Extended satiety
Utilizing self reported food intake, looking for changes associated with the different proetin compositions of the shakes.
Full Information
NCT ID
NCT01587911
First Posted
April 26, 2012
Last Updated
August 10, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01587911
Brief Title
Casinomacropeptide and Satiety
Acronym
CMP2
Official Title
Characterization of the Physiological and Subjective Satiety Response to Preloads Varying in Bioactive Dairy Proteins
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle.
Detailed Description
Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle. Subjects will attend a 5 hour post-prandial study day. Subjects will keep food records 1 and 3 days prior to study visit, day of visit, and day after visit; food to be weighed using study provided dietary scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lack of Satiety, Excess Intake of Macronutrients, Appetite Disorders
Keywords
Satiety, Food intake regulation, Appetite regulation, Dairy Protein
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whey protein
Arm Type
Active Comparator
Arm Description
Complete whey protein.
Arm Title
Whey-CMP
Arm Type
Active Comparator
Arm Description
Complete whey protein missing the CMP (aka GMP) portion of the peptide.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo preload control, matched for energy.
Arm Title
CMP (casinomacropeptide)
Arm Type
Active Comparator
Arm Description
Small peptide cleaved from complete whey protein.
Arm Title
MPI
Arm Type
Active Comparator
Arm Description
Complete milk protein.
Arm Title
CPI (casein)
Arm Type
Active Comparator
Arm Description
Preload containing casein.
Intervention Type
Other
Intervention Name(s)
Whey
Other Intervention Name(s)
Whey.
Intervention Description
Preload containing complete whey protein.
Intervention Type
Other
Intervention Name(s)
Whey-CMP
Intervention Description
Preload containing complete whey protein which is missing the CMP/GMP portion of the protein.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Preload control matched for energy to the other 5 preloads.
Intervention Type
Other
Intervention Name(s)
CMP
Other Intervention Name(s)
casinomacropeptide
Intervention Description
Preload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein.
Intervention Type
Other
Intervention Name(s)
MPI
Other Intervention Name(s)
Whole milk protein
Intervention Description
Preload containing whole milk protein.
Intervention Type
Other
Intervention Name(s)
CPI
Other Intervention Name(s)
Casein
Intervention Description
Preload containing sodium caseinate.
Primary Outcome Measure Information:
Title
Post-prandial satiety
Description
Blood biochemical markers of appetite regulation.
Time Frame
6 hours
Title
Post-prandial satiety
Description
Assessing biobehavioral aspects of appetite regulation through VAS.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Extended satiety
Description
Utilizing self reported food intake, looking for changes associated with the different proetin compositions of the shakes.
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Unrestrained (score ≤ 10 on the Eating Inventory (EI) questionnaire, Stunkard and Messick 1985)
Women
18 years of age
Consume a low/moderate protein diet (12-20% protein energy).
Meet BMI criteria of 19 to 24 kg/m2 OR 29 to 34 kg/m2, inclusive.
Exclusion Criteria:
Women who score ≥ 10 on the Beck Depression Inventory (BDI, Beck and Beamesdorfer 1974)
Women who score ≥ 30 on Eating Attitudes Test (EAT, Garner and Garfinkel 1979),
Have current or past (previous 1 year) medical conditions that may interfere with any of the outcomes of this study.
Weigh less than 110 lbs
Are currently or have been modifying diet or exercise patterns to gain or lose weight in previous 60 days
Have unstable body weight (fluctuations of ≥ 5 kg in 60 day period)
Are excessive exercisers or trained athletes
Taking any medications that would affect appetite or any other study-described endpoint will also be excluded.
Allergies or intolerances to foods consumed in the study.
Smoker
Pregnant/lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britt Burton-Freeman, PhD, MS
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis (Ragle Human Nutrition Research Center)
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Casinomacropeptide and Satiety
We'll reach out to this number within 24 hrs