Casinomacropeptide and Satiety (CMP2)

University of California (UC) Davis

Status: Completed

Conditions: Excess Intake of Macronutrients; Appetite Disorders; Lack of Satiety

Treatments: Other: CMP; Other: Control; Other: MPI; Other: Whey-CMP; Other: CPI; Other: Whey

Study type: Interventional

Funder types: Other

Identifiers

NCT01587911

200614016

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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20 participants in 6 patient groups, including a placebo group

Whey protein

Active Comparator group

Description:

Complete whey protein.

Treatment:

Other: Whey

Whey-CMP

Active Comparator group

Description:

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

Treatment:

Other: Whey-CMP

Control

Placebo Comparator group

Description:

Placebo preload control, matched for energy.

Treatment:

Other: Control

CMP (casinomacropeptide)

Active Comparator group

Description:

Small peptide cleaved from complete whey protein.

Treatment:

Other: CMP

MPI

Active Comparator group

Description:

Complete milk protein.

Treatment:

Other: MPI

CPI (casein)

Active Comparator group

Description:

Preload containing casein.

Treatment:

Other: CPI