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OpenTrials
Completed

NCT Number: NCT01587911

Casinomacropeptide and Satiety

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

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey

Other

Preload containing complete whey protein.

Other names: Whey.

Whey-CMP

Other

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

Control

Other

Preload control matched for energy to the other 5 preloads.

CMP

Other

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

Other names: casinomacropeptide

MPI

Other

Preload containing whole milk protein.

Other names: Whole milk protein

CPI

Other

Preload containing sodium caseinate.

Other names: Casein

Primary outcomes

  1. Post-prandial satiety

    Time frame: 6 hours

    Blood biochemical markers of appetite regulation.

  2. Post-prandial satiety

    Time frame: 6 hours

    Assessing biobehavioral aspects of appetite regulation through VAS.

Secondary outcomes

  1. Extended satiety

    Time frame: 48 hours

    Utilizing self reported food intake, looking for changes associated with the different proetin compositions of the shakes.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Acronym: CMP2

Important dates

Study start
2008
Primary completion
2009
Study completion
2015
First posted
Apr 30, 2012
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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