Casinomacropeptide and Satiety (CMP2)

August 10, 2017 updated by: University of California, Davis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California, Davis (Ragle Human Nutrition Research Center)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Britt Burton-Freeman, PhD, MS, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200614016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Appetite Disorders

Clinical Trials on Whey

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe