Casinomacropeptide and Satiety

Appetite Disorders Clinical Trial

— CMP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587911
• Other study ID #: 200614016
• Status: Completed
• Phase: N/A
• First received: April 26, 2012
• Last updated: August 10, 2017
• Start date: May 2008
• Est. completion date: September 2015

Study information

• Verified date: August 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite Disorders
• Excess Intake of Macronutrients
• Feeding and Eating Disorders
• Lack of Satiety

Intervention

Other:
• Whey
Preload containing complete whey protein.
• Whey-CMP
Preload containing complete whey protein which is missing the CMP/GMP portion of the protein.
• Control
Preload control matched for energy to the other 5 preloads.
• CMP
Preload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein.
• MPI
Preload containing whole milk protein.
• CPI
Preload containing sodium caseinate.

Locations

Country	Name	City	State
United States	University of California, Davis (Ragle Human Nutrition Research Center)	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-prandial satiety	Blood biochemical markers of appetite regulation.	6 hours
Primary	Post-prandial satiety	Assessing biobehavioral aspects of appetite regulation through VAS.	6 hours
Secondary	Extended satiety	Utilizing self reported food intake, looking for changes associated with the different proetin compositions of the shakes.	48 hours