Casinomacropeptide and Satiety

NCT ID: NCT01587911

Last Updated: 2017-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2015-09-30

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.

Conditions

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Lack of Satiety Excess Intake of Macronutrients Appetite Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Whey protein

Complete whey protein.

Group Type ACTIVE_COMPARATOR

Whey

Intervention Type OTHER

Preload containing complete whey protein.

Whey-CMP

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

Group Type ACTIVE_COMPARATOR

Whey-CMP

Intervention Type OTHER

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

Control

Placebo preload control, matched for energy.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Preload control matched for energy to the other 5 preloads.

CMP (casinomacropeptide)

Small peptide cleaved from complete whey protein.

Group Type ACTIVE_COMPARATOR

CMP

Intervention Type OTHER

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

MPI

Complete milk protein.

Group Type ACTIVE_COMPARATOR

MPI

Intervention Type OTHER

Preload containing whole milk protein.

CPI (casein)

Preload containing casein.

Group Type ACTIVE_COMPARATOR

CPI

Intervention Type OTHER

Preload containing sodium caseinate.

Interventions

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Whey

Preload containing complete whey protein.

Intervention Type OTHER

Whey-CMP

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

Intervention Type OTHER

Control

Preload control matched for energy to the other 5 preloads.

Intervention Type OTHER

CMP

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

Intervention Type OTHER

MPI

Preload containing whole milk protein.

Intervention Type OTHER

CPI

Preload containing sodium caseinate.

Intervention Type OTHER

Other Intervention Names

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Whey. casinomacropeptide Whole milk protein Casein

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Britt Burton-Freeman, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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200614016

Identifier Type: -

Identifier Source: org_study_id

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