Body Composition, BeneficialMRPNCT02482545
Breakfast Meal Replacement
A study testing Meal replacement in people with Body Composition, Beneficial and Basal Metabolic Rate, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high fiber meal replacement in overweight individuals, on body composition. Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of disease. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Beneficial, Basal Metabolic Rate, Satiety
- What is being tested?
- Meal replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, Overweight Men and Pre-Menopausal Women
- Participant agrees to maintain usual activity lifestyle
- Participant has a body mass index of ≥ 28 (men) and ≥25 (women) kg/m2 and/or %body fat of ≥ 25%
- Participant has provided written and dated informed consent to participate in the study
- Participant is willing and able to comply with the protocol
- Participant is apparently healthy and free from disease, as determined by a health history questionnaire (diabetes, heart disease, kidney disease, cancer, thyroid disorder, etc).
- Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days
- Participant has stated a goal of losing weight or improving body composition
Who cannot join
- Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders (i.e. anything influencing exercise ability).
- Participant is using, or has used one of the following dietary supplements within 8 weeks prior to enrollment: Meal replacement shakes, Whey Protein, Beta-alanine, Creatine, beta-hydroxy beta methylbutyrate, Carnosine or Taurine
- Participant has lost or gained greater than ten pounds within the previous 3 months
- Participant is in, or has participated in another clinical trial within 4 weeks prior to enrollment
- Participant had or currently has a self-identified eating disorder
- Participant is pregnant or plans to become pregnant during the duration of the study
- Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory
Chapel Hill, North Carolina, 27599
About this study
Official title: Breakfast Meal Replacement Use on Body Composition and Health-related Quality of Life in Overweight Men and Women: a Randomized Controlled Trial
Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high fiber meal replacement in overweight individuals, on body composition.
Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of disease. Procedures (methods): In a randomized control intervention, subjects will complete 5 different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing sessions) as well as an 8 week intervention period. Pre-screening will include written informed consent, health history questionnaire, nutrition analysis, and baseline anthropometric measures. Baseline testing will be split into two sessions and include measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones, mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory fitness assessment.
Subjects will be randomly assigned to treatment (8 week supplementation with meal replacement to be taken at breakfast) and control groups (continue normal eating habits) with 4 electronic correspondences throughout the supplementation period. All measures will be repeated in two post-testing sessions.
- Conditions
- Body Composition, Beneficial, Basal Metabolic Rate, Satiety, Overweight, Obese
- Being tested
- Meal replacement
- Medical subject headings
- Glucocorticoid Receptor Deficiency, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal replacementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Breakfast Meal Replacement | Experimental | Once daily of a powdered meal replacement (high fat, high protein) will be consumed, mixed with water, at breakfast. Receives: Dietary Supplement: Meal replacement |
| Control | No intervention | No placebo or intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Mass measured from multi-compartment (4C) model
Measured: 0 to 8 weeks
Secondary outcomes (10)
Change in lean mass measured from multi-compartment (4C) model
Measured: 0 to 8 weeks
Change in percent body fat measured from multi-compartment (4C) model
Measured: 0 to 8 weeks
Change in resting metabolic rate using indirect calorimetry
Measured: 0 to 8 weeks
Change in respiratory exchange ratio using indirect calorimetry
Measured: 0 to 8 weeks
Change in total leptin concentrations from blood sample analysis
Measured: 0 to 8 weeks
Change in LDL from blood sample analysis
Measured: 0 to 8 weeks
Change in triglycerides from blood sample analysis
Measured: 0 to 8 weeks
Change in insulin from blood sample analysis
Measured: 0 to 8 weeks
Change in visceral fat from ultrasonography
Measured: 0 to 8 weeks
Change in satiety via questionnaire
Measured: 0 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition, BeneficialStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill
- Investigators
- Abbie Smith-Ryan, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482545
- Sponsor's protocol ID
- 15-0543
- Acronym
- MRP
- Status last verified
- Mar 2016
- First submitted
- 22 Jun 2015
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakfast Meal Replacement Use on Body Composition and Health-related Quality of Life in Overweight Men and Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02482545
- Acronym / sponsor ID
- MRP / 15-0543
- Conditions
- Body Composition, Beneficial, Basal Metabolic Rate, Satiety, Overweight, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Jun 2015 (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.
Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high fiber meal replacement in overweight individuals, on body composition.
Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of disease. Procedures (methods): In a randomized control intervention, subjects will complete 5 different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing sessions) as well as an 8 week intervention period. Pre-screening will include written informed consent, health history questionnaire, nutrition analysis, and baseline anthropometric measures. Baseline testing will be split into two sessions and include measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones, mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory fitness assessment.
Subjects will be randomly assigned to treatment (8 week supplementation with meal replacement to be taken at breakfast) and control groups (continue normal eating habits) with 4 electronic correspondences throughout the supplementation period. All measures will be repeated in two post-testing sessions.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breakfast Meal Replacement | Experimental | Dietary Supplement: Meal replacementOnce daily of a powdered meal replacement (high fat, high protein) will be consumed, mixed with water, at breakfast. |
| Control | No intervention | –No placebo or intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, Overweight Men and Pre-Menopausal Women
- Participant agrees to maintain usual activity lifestyle
- Participant has a body mass index of ≥ 28 (men) and ≥25 (women) kg/m2 and/or %body fat of ≥ 25%
- Participant has provided written and dated informed consent to participate in the study
- Participant is willing and able to comply with the protocol
Key exclusion criteria (7 listed)
- Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders (i.e. anything influencing exercise ability).
- Participant is using, or has used one of the following dietary supplements within 8 weeks prior to enrollment: Meal replacement shakes, Whey Protein, Beta-alanine, Creatine, beta-hydroxy beta methylbutyrate, Carnosine or Taurine
- Participant has lost or gained greater than ten pounds within the previous 3 months
- Participant is in, or has participated in another clinical trial within 4 weeks prior to enrollment
- Participant had or currently has a self-identified eating disorder
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 |
|---|---|---|
| Meal replacement | Dietary supplement | Breakfast Meal Replacement |
Primary outcome
Change in Fat Mass measured from multi-compartment (4C) model
Time frame: 0 to 8 weeks
10 secondary outcomes
Change in lean mass measured from multi-compartment (4C) model
Time frame: 0 to 8 weeks
Change in percent body fat measured from multi-compartment (4C) model
Time frame: 0 to 8 weeks
Change in resting metabolic rate using indirect calorimetry
Time frame: 0 to 8 weeks
Change in respiratory exchange ratio using indirect calorimetry
Time frame: 0 to 8 weeks
Change in total leptin concentrations from blood sample analysis
Time frame: 0 to 8 weeks
Change in LDL from blood sample analysis
Time frame: 0 to 8 weeks
Change in triglycerides from blood sample analysis
Time frame: 0 to 8 weeks
Change in insulin from blood sample analysis
Time frame: 0 to 8 weeks
Change in visceral fat from ultrasonography
Time frame: 0 to 8 weeks
Change in satiety via questionnaire
Time frame: 0 to 8 weeks
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 8 Mar 2016.
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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.
Abbie Smith-Ryan principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal replacement in people with Body Composition, Beneficial and Basal Metabolic Rate, run by University of North Carolina, Chapel Hill 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 8 inclusion and 7 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 8 Mar 2016. 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. 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?
Change in Fat Mass measured from multi-compartment (4C) model (time frame: 0 to 8 weeks). 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 8 Mar 2016.