Lack of SatietyCMP2NCT01587911
Casinomacropeptide and Satiety
A study testing Whey, Whey-CMP and CMP in people with Lack of Satiety and Excess Intake of Macronutrients, run by University of California, Davis at 1 site in United States.
Trial summary
Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lack of Satiety, Excess Intake of Macronutrients, Appetite Disorders
- What is being tested?
- Whey, Whey-CMP and CMP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis (Ragle Human Nutrition Research Center)
Davis, California, 95616
About this study
Official title: Characterization of the Physiological and Subjective Satiety Response to Preloads Varying in Bioactive Dairy Proteins
Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle.
Read the detailed 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.
- Being tested
- Whey, Whey-CMP, Control, CMP, MPI
- Keywords
- Satiety, Food intake regulation, Appetite regulation, Dairy Protein
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WheyOther
Also called Whey.
Preload containing complete whey protein.
Whey-CMPOther
Preload containing complete whey protein which is missing the CMP/GMP portion of the protein.
ControlOther
Preload control matched for energy to the other 5 preloads.
CMPOther
Also called casinomacropeptide
Preload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein.
MPIOther
Also called Whole milk protein
Preload containing whole milk protein.
CPIOther
Also called Casein
Preload containing sodium caseinate.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein | Active comparator | Complete whey protein. Receives: Other: Whey |
| Whey-CMP | Active comparator | Complete whey protein missing the CMP (aka GMP) portion of the peptide. Receives: Other: Whey-CMP |
| Control | Placebo comparator | Placebo preload control, matched for energy. Receives: Other: Control |
| CMP (casinomacropeptide) | Active comparator | Small peptide cleaved from complete whey protein. Receives: Other: CMP |
| MPI | Active comparator | Complete milk protein. Receives: Other: MPI |
| CPI (casein) | Active comparator | Preload containing casein. Receives: Other: CPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial satiety
Blood biochemical markers of appetite regulation.
Measured: 6 hours
Post-prandial satiety
Assessing biobehavioral aspects of appetite regulation through VAS.
Measured: 6 hours
Secondary outcomes (1)
Extended satiety
Utilizing self reported food intake, looking for changes associated with the different proetin compositions of the shakes.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lack of SatietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, PhD, MS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587911
- Sponsor's protocol ID
- 200614016
- Acronym
- CMP2
- Status last verified
- Aug 2017
- First submitted
- 26 Apr 2012
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Physiological and Subjective Satiety Response to Preloads Varying in Bioactive Dairy Proteins
- ClinicalTrials.gov ID
- NCT01587911
- Acronym / sponsor ID
- CMP2 / 200614016
- Keywords
- Satiety, Food intake regulation, Appetite regulation, Dairy Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Whey protein | Active comparator | Other: WheyComplete whey protein. |
| Whey-CMP | Active comparator | Other: Whey-CMPComplete whey protein missing the CMP (aka GMP) portion of the peptide. |
| Control | Placebo comparator | Other: ControlPlacebo preload control, matched for energy. |
| CMP (casinomacropeptide) | Active comparator | Other: CMPSmall peptide cleaved from complete whey protein. |
| MPI | Active comparator | Other: MPIComplete milk protein. |
| CPI (casein) | Active comparator | Other: CPIPreload containing casein. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WheyAlso: Whey.Preload containing complete whey protein. | Other | Whey protein |
| Whey-CMPPreload containing complete whey protein which is missing the CMP/GMP portion of the protein. | Other | Whey-CMP |
| ControlPreload control matched for energy to the other 5 preloads. | Other | Control |
| CMPAlso: casinomacropeptidePreload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein. | Other | CMP (casinomacropeptide) |
| MPIAlso: Whole milk proteinPreload containing whole milk protein. | Other | MPI |
| CPIAlso: CaseinPreload containing sodium caseinate. | Other | CPI (casein) |
Primary outcome
Post-prandial satiety
Time frame: 6 hours
Blood biochemical markers of appetite regulation.
Post-prandial satiety
Time frame: 6 hours
Assessing biobehavioral aspects of appetite regulation through VAS.
1 secondary outcome
Extended satiety
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt Burton-Freeman, PhD, MS principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey, Whey-CMP and CMP in people with Lack of Satiety and Excess Intake of Macronutrients, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial satiety (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.