This trial is active, not recruiting.

Conditions lack of satiety, excess intake of macronutrients, appetite disorders
Treatments whey, whey-cmp, control, cmp, mpi, cpi
Sponsor University of California, Davis
Start date May 2008
End date May 2009
Trial size 20 participants
Trial identifier NCT01587911, 200614016


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose basic science
(Active Comparator)
Complete whey protein.
whey Whey.
Preload containing complete whey protein.
(Active Comparator)
Complete whey protein missing the CMP (aka GMP) portion of the peptide.
whey-cmp Whey-CMP
Preload containing complete whey protein which is missing the CMP/GMP portion of the protein.
(Placebo Comparator)
Placebo preload control, matched for energy.
control Control
Preload control matched for energy to the other 5 preloads.
(Active Comparator)
Small peptide cleaved from complete whey protein.
cmp CMP
Preload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein.
(Active Comparator)
Complete milk protein.
mpi MPI
Preload containing whole milk protein.
(Active Comparator)
Preload containing casein.
cpi CPI
Preload containing sodium caseinate.

Primary Outcomes

Post-prandial satiety
time frame: 6 hours
Post-prandial satiety
time frame: 6 hours

Secondary Outcomes

Extended satiety
time frame: 48 hours

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Characterization of the Physiological and Subjective Satiety Response to Preloads Varying in Bioactive Dairy Proteins
Principal investigator Britt Burton-Freeman, PhD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of California, Davis.