NCT01587911

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

April 26, 2012

Last Update Submit

August 10, 2017

Conditions

Lack of SatietyExcess Intake of MacronutrientsAppetite Disorders

Keywords

SatietyFood intake regulationAppetite regulationDairy Protein

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Extended satiety

    48 hours

Study Arms (6)

Whey protein

ACTIVE COMPARATOR

Complete whey protein.

Other: Whey

Whey-CMP

ACTIVE COMPARATOR

Complete whey protein missing the CMP (aka GMP) portion of the peptide.

Other: Whey-CMP

Control

PLACEBO COMPARATOR

Placebo preload control, matched for energy.

Other: Control

CMP (casinomacropeptide)

ACTIVE COMPARATOR

Small peptide cleaved from complete whey protein.

Other: CMP

MPI

ACTIVE COMPARATOR

Complete milk protein.

Other: MPI

CPI (casein)

ACTIVE COMPARATOR

Preload containing casein.

Other: CPI

Interventions

WheyOTHER

Preload containing complete whey protein.

Also known as: Whey.
Whey protein
Whey-CMPOTHER

Preload containing complete whey protein which is missing the CMP/GMP portion of the protein.

Whey-CMP
ControlOTHER

Preload control matched for energy to the other 5 preloads.

Control
CMPOTHER

Preload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein.

Also known as: casinomacropeptide
CMP (casinomacropeptide)
MPIOTHER

Preload containing whole milk protein.

Also known as: Whole milk protein
MPI
CPIOTHER

Preload containing sodium caseinate.

Also known as: Casein
CPI (casein)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Unrestrained (score ≤ 10 on the Eating Inventory (EI) questionnaire, Stunkard and Messick 1985)
  • Women
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis (Ragle Human Nutrition Research Center)

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

WheyCytidine MonophosphatecyclopropapyrroloindoleCaseins

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesMilk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPhosphoproteins

Study Officials

  • Britt Burton-Freeman, PhD, MS

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2012

First Posted

April 30, 2012

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

September 1, 2015

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

US(1)