Casinomacropeptide and Satiety

Study Overview
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Brief Summary
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Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle.

Detailed Description
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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.

Official Title
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Characterization of the Physiological and Subjective Satiety Response to Preloads Varying in Bioactive Dairy Proteins

Conditions
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Lack of Satiety, Excess Intake of Macronutrients, Appetite Disorders

Intervention / Treatment
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* Other: Whey
* Other: Whey-CMP
* Other: Control
* Other: CMP
* Other: MPI
* Other: CPI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whey protein<br>Complete whey protein. | Other: Whey<br>* Preload containing complete whey protein.<br>* Other names: Whey.;|
| Active Comparator: Whey-CMP<br>Complete whey protein missing the CMP (aka GMP) portion of the peptide. | Other: Whey-CMP<br>* Preload containing complete whey protein which is missing the CMP/GMP portion of the protein.<br>|
| Placebo Comparator: Control<br>Placebo preload control, matched for energy. | Other: Control<br>* Preload control matched for energy to the other 5 preloads.<br>|
| Active Comparator: CMP (casinomacropeptide)<br>Small peptide cleaved from complete whey protein. | Other: CMP<br>* Preload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein.<br>* Other names: casinomacropeptide;|
| Active Comparator: MPI<br>Complete milk protein. | Other: MPI<br>* Preload containing whole milk protein.<br>* Other names: Whole milk protein;|
| Active Comparator: CPI (casein)<br>Preload containing casein. | Other: CPI<br>* Preload containing sodium caseinate.<br>* Other names: Casein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial satiety | Blood biochemical markers of appetite regulation. | 6 hours | 
| Post-prandial satiety | Assessing biobehavioral aspects of appetite regulation through VAS. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extended satiety | Utilizing self reported food intake, looking for changes associated with the different proetin compositions of the shakes. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Satiety, Food intake regulation, Appetite regulation, Dairy Protein