Body Composition, BeneficialS38NCT02066948
Meal Patterning on Weight Loss With Changes to Body Comp, Muscle and Metabolic Health
A study testing wt loss, Meal Pattern and even in people with Body Composition, Beneficial and Paresis, run by Purdue University at 1 site in United States.
Trial summary
About two-thirds of adults in the United States are overweight or obese with likely adverse health consequences. A Moderate weight loss by dieting and exercise is recommended to improve health. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Beneficial, Paresis, Impaired Glucose Tolerance
- What is being tested?
- wt loss, Meal Pattern and even
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking;
- weight stable (± 4.5 kg during previous 3 months)
- constant habitual activity patterns within last 3 months
- no acute illness
- not diabetic or have chronic diseases
- blood profile within 10% of clinical normalcy
Show all 11Show fewer
- subjects not classified as high risk for cardiovascular disease
- no use of medications
- females who are not pregnant or lactating
- ability to travel to testing and exercise training facilities
- not claustrophobic and able to complete the muscle size testing using the magnetic resonance imager
Who cannot join
- Smoker
- weight changed within 3 months
- a history of disease or high risk of cardiovascular disease
- history of claustrophobic
- pregnant or lactating female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dietary Protein Patterning on wt Loss and Resistance Training-induced Changes in Body Comp, Skeletal Muscle, and Indices of Metabolic Syndrome
About two-thirds of adults in the United States are overweight or obese with likely adverse health consequences. A Moderate weight loss by dieting and exercise is recommended to improve health. We are interested to know whether eating dietary protein at different times of the day influences changes in body composition, muscle and indices of health. The purpose of this study is to examine the effects of within-day patterning of dietary protein intake (even vs. skewed) on energy-restriction and resistance training-induced changes in body composition, muscle size, appetite, and clinical health (including blood glucose and blood pressure).
Read the detailed description
About two-thirds of adults in the United States are overweight or obese. Obesity is associated with an increased risk of chronic disease and metabolic syndrome and a reduced physical functioning capacity, all of which contribute to disproportionately high healthcare expenditures and premature mortality. A moderate dietary energy restriction with a higher protein diet has been recommended for weight loss to prevent or improve medical complications associated with obesity as well as improve body composition, including preserving lean body mass. Emerging research indicates that the consumption of multiple high protein meals daily may be superior than only consuming one high-protein meal (typically dinner) to stimulate muscle protein synthesis throughout the day. This concept is based on research showing that the patterning of energy and protein intake influences muscle protein synthesis and whole body composition and protein retention. Very limited research exists regarding the effects of protein intake on skeletal muscle size after weight loss, and currently, no longitudinal studies have evaluated the effectiveness of consuming an even vs. skewed distribution of protein intake across meals on phenotypic changes in skeletal muscle size over the longer-term. Recent studies have also suggested that evenly distributed protein patterning may promote satiety and improve blood glucose response in healthy adult men and women. However, there is a need for controlled, longer-duration trials to investigate the effects of daily protein distribution on appetite, glucose response and metabolic syndrome after weight loss in overweight or obese adults. The goal of the proposed research is to evaluate the effects of within-day patterning of dietary protein intake (even vs. skewed) on energy-restriction and resistance training-induced changes in body composition, skeletal muscle size, appetite, glucose response, and metabolic syndrome parameters.
- Being tested
- wt loss, Meal Pattern, even, skew
- Keywords
- DXA, MRI, Fitness assessment, Meal tolerance test
- Medical subject headings
- Glucocorticoid Receptor Deficiency, Paresis, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wt lossOther
subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age
Meal PatternOther
Even or skewed distribution of protein for a 16 week period of wt loss.
meal patternOther
Also called skew or even
skew or even
evenDietary supplement
even amount of protein distributed between each meal
skewDietary supplement
a skewed amount of protein is distributed between each meal
| Study group | Role | What they receive |
|---|---|---|
| Skew meal pattern w/ wt loss&exercise | Active comparator | Skew meal pattern w/ wt loss\&exercise e Receives: Other: wt loss; Other: Meal Pattern; Dietary Supplement: even |
| even meal pattern w/ wt loss&exercise | Active comparator | even meal pattern w/ wt loss\&exercise Receives: Other: wt loss; Other: Meal Pattern; Dietary Supplement: skew |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Fasting-state body weight and waist and hip circumferences will be measured. Body composition (fat mass, lean body mass, and bone mass) will also be determined using Dual Energy X-ray Absorptiometry (DXA, GE Healthcare LUNAR iDXA™ with EnCORE software version 5.60, Madison, WI).
Measured: 20 weeks
Body composition
Fasting-state body weight and waist and hip circumferences will be measured. Body composition (fat mass, lean body mass, and bone mass) will also be determined using Dual Energy X-ray Absorptiometry
Measured: 20 weeks
Secondary outcomes (1)
Whole body Imaging
A total of 2 magnetic resonance imaging (MRI) images of muscle and 1 MRI of the abdomen will be obtained
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- National Pork Board, American Egg Board, Dairy Research Institute, National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph.D., Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066948
- Sponsor's protocol ID
- 1307013804
- Acronym
- S38
- Status last verified
- Jan 2017
- First submitted
- 12 Sep 2013
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hudson JL, Kim JE, Paddon-Jones D, Campbell WW. Within-day protein distribution does not influence body composition responses during weight loss in resistance-training adults who are overweight. Am J Clin Nutr. 2017 Nov;106(5):1190-1196. doi: 10.3945/ajcn.117.158246. Epub 2017 Sep 13.
PubMed 28903957
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Protein Patterning on wt Loss and Resistance Training-induced Changes in Body Comp, Skeletal Muscle, and Indices of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02066948
- Acronym / sponsor ID
- S38 / 1307013804
- Keywords
- DXA, MRI, Fitness assessment, Meal tolerance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- National Pork Board, American Egg Board, Dairy Research Institute, National Cattlemen's Beef Association, a contractor to the Beef Checkoff
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Feb 2014 (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.
About two-thirds of adults in the United States are overweight or obese with likely adverse health consequences. A Moderate weight loss by dieting and exercise is recommended to improve health. We are interested to know whether eating dietary protein at different times of the day influences changes in body composition, muscle and indices of health. The purpose of this study is to examine the effects of within-day patterning of dietary protein intake (even vs. skewed) on energy-restriction and resistance training-induced changes in body composition, muscle size, appetite, and clinical health (including blood glucose and blood pressure).
Detailed description
About two-thirds of adults in the United States are overweight or obese. Obesity is associated with an increased risk of chronic disease and metabolic syndrome and a reduced physical functioning capacity, all of which contribute to disproportionately high healthcare expenditures and premature mortality. A moderate dietary energy restriction with a higher protein diet has been recommended for weight loss to prevent or improve medical complications associated with obesity as well as improve body composition, including preserving lean body mass. Emerging research indicates that the consumption of multiple high protein meals daily may be superior than only consuming one high-protein meal (typically dinner) to stimulate muscle protein synthesis throughout the day. This concept is based on research showing that the patterning of energy and protein intake influences muscle protein synthesis and whole body composition and protein retention. Very limited research exists regarding the effects of protein intake on skeletal muscle size after weight loss, and currently, no longitudinal studies have evaluated the effectiveness of consuming an even vs. skewed distribution of protein intake across meals on phenotypic changes in skeletal muscle size over the longer-term. Recent studies have also suggested that evenly distributed protein patterning may promote satiety and improve blood glucose response in healthy adult men and women. However, there is a need for controlled, longer-duration trials to investigate the effects of daily protein distribution on appetite, glucose response and metabolic syndrome after weight loss in overweight or obese adults. The goal of the proposed research is to evaluate the effects of within-day patterning of dietary protein intake (even vs. skewed) on energy-restriction and resistance training-induced changes in body composition, skeletal muscle size, appetite, glucose response, and metabolic syndrome parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skew meal pattern w/ wt loss&exercise | Active comparator | Other: wt loss, Other: Meal Pattern, Dietary Supplement: evenSkew meal pattern w/ wt loss\&exercise e |
| even meal pattern w/ wt loss&exercise | Active comparator | Other: wt loss, Other: Meal Pattern, Dietary Supplement: skeweven meal pattern w/ wt loss\&exercise |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- non-smoking;
- weight stable (± 4.5 kg during previous 3 months)
- constant habitual activity patterns within last 3 months
- no acute illness
- not diabetic or have chronic diseases
Key exclusion criteria (5 listed)
- Smoker
- weight changed within 3 months
- a history of disease or high risk of cardiovascular disease
- history of claustrophobic
- pregnant or lactating female
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 |
|---|---|---|
| wt losssubjects will consume a 750 reduced calorie daily diet based on current ht. wt and age | Other | Skew meal pattern w/ wt loss&exercise, even meal pattern w/ wt loss&exercise |
| Meal PatternEven or skewed distribution of protein for a 16 week period of wt loss. | Other | Skew meal pattern w/ wt loss&exercise, even meal pattern w/ wt loss&exercise |
| meal patternAlso: skew or evenskew or even | Other | Skew meal pattern w/ wt loss&exercise, even meal pattern w/ wt loss&exercise |
| eveneven amount of protein distributed between each meal | Dietary supplement | Skew meal pattern w/ wt loss&exercise |
| skewa skewed amount of protein is distributed between each meal | Dietary supplement | even meal pattern w/ wt loss&exercise |
Primary outcome
Body composition
Time frame: 20 weeks
Fasting-state body weight and waist and hip circumferences will be measured. Body composition (fat mass, lean body mass, and bone mass) will also be determined using Dual Energy X-ray Absorptiometry (DXA, GE Healthcare LUNAR iDXA™ with EnCORE software version 5.60, Madison, WI).
Body composition
Time frame: 20 weeks
Fasting-state body weight and waist and hip circumferences will be measured. Body composition (fat mass, lean body mass, and bone mass) will also be determined using Dual Energy X-ray Absorptiometry
1 secondary outcome
Whole body Imaging
Time frame: 20 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 1 Jun 2017.
- Derived from this study: PubMed 28903957Hudson JL, Kim JE, Paddon-Jones D, Campbell WW. Within-day protein distribution does not influence body composition responses during weight loss in resistance-training adults who are overweight. Am J Clin Nutr. 2017 Nov;106(5):1190-1196. doi: 10.3945/ajcn.117.158246. Epub 2017 Sep 13.
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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.
Wayne W Campbell, Ph.D. principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wt loss, Meal Pattern and even in people with Body Composition, Beneficial and Paresis, run by Purdue University 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 11 inclusion and 5 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 1 Jun 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. 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?
Body composition (time frame: 20 weeks). 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?
On the ClinicalTrials.gov record for NCT02066948, which also lists 1 linked publication.
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 1 Jun 2017.