ObesityPRIMONCT01410643
Puberty Related Intervention to Improve Metabolic Outcomes (The PRIMO Study)
A study testing Macronutrient Modification in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Puberty represents a critical period in terms of metabolic health. Racial differences in insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a female's health later in life. Read more about this study
- Who is it for?
- Ages 7 to 11 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Macronutrient Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 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 7 to 11 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Self-identified as African American or European American
- Aged 7-11 AND Tanner stage < 3
- Overweight (BMI percentile 85-97th)
- Not taking any medication known to affect body composition
- No prior diagnosis of chronic condition
Who cannot join
- Illness that precludes study participation
- Prescribed medication known to affect body composition
- Not of EA or AA racial/ethnic group
- Obese (BMI% > 97th) or normal weight (BMI% < 85th)
- Reproductively mature as define by Tanner stage > 3
Trial locations and contacts
1 site in 1 country.
About this study
Puberty represents a critical period in terms of metabolic health. Racial differences in insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a female's health later in life. Further, the peripubertal period is likely the period of racial divergence in adiposity noted between European American (EA) and African American (AA) girls. Diet is a major modifiable risk factor. The identification of simple, cost-effective dietary strategies for prevention and management of metabolic disease and excess fat mass accrual during the peripubertal period is a priority. Modification of the diet to affect metabolic and endocrine outcomes with and without weight loss during the pubertal transition represents a novel approach to the pediatric obesity epidemic.
It is likely that the two diets used in this project will have different metabolic effects, including effects on postprandial glycemia, triglyceride concentration, free fatty acid concentration, and satiety. These factors may in turn, affect development of metabolic perturbations, especially in susceptible individuals (e.g. AA peripubertal girls).The role of carbohydrates on metabolic outcomes, particularly among children, has received little attention. It has been hypothesized that higher postprandial glycemia may be a mechanism for disease progression. Development of a diet that reduces insulin secretion and optimizes metabolic-endocrine health among peripubertal girls will likely reduce obesity and related co-morbidities and future reliance on pharmacologic treatments, even in the absence of weight loss. However, in light of the current trends in pediatric obesity, a safe and effective regimen that also promotes weight loss is needed for the pediatric population.
This proposal is significant in that it will shed light on whether diet composition, as a part of a eucaloric (weight-stable) or hypocaloric diet (weight-loss) can influence the hyperinsulinemic characteristic of AA peripubertal girls. Existing data suggest that elevated concentrations of insulin and/or reproductive hormones may contribute to the fat mass accrual in AA and could elevate risks for development of chronic diseases in adulthood. The results of this study will lead to the development of dietary means for the reduction of insulin, and thereby to the prevention of both pediatric obesity and type 2 diabetes.
Read the detailed description
This study will include 100 European and African American girls ages 7-11 years. Subjects must be non-diabetic and overweight (percentile BMI >85th ).
Screening First they will complete a telephone questionnaire regarding medical history and current lifestyle (approximately 15 minutes). If the subject is deemed eligible based on the telephone screening, they will come to UAB for an orientation meeting. At this time the subjects' height and weight will be recorded. They will receive a copy of the study assent/consent form and review the entire protocol with selected study personnel (approximately 60 minutes).
Protocol
Run-In Phase With parental guidance, subjects will complete a 4-day food record for assessment of typical nutrient intake (attached) prior to beginning the run-in diet. The 4-day food record will be analyzed by a registered dietitian using the Minnesota Nutrition Data System. Then subjects will be provided food for 3 days. This diet is similar to the standard "American" diet, and is intended to eliminate inter-subject variance in metabolic outcomes due to free-living dietary factors. The total energy of all diets will be calculated to be eucaloric so that body weight is maintained, and will be determined using the Harris-Benedict equation with an activity factor of 1.35. In previous and ongoing studies at the UAB CRU, this method has resulted in maintenance of body mass. Subjects will come to UAB to be weighed and pick up meals. All meals will be packaged for home consumption. Upon completion of the Run-in Phase, subjects will report to the CRU Outpatient facilities for metabolic testing and WEBB and Boshell buildings for body composition assessment. The tests administered are described below.
Phase 1 Weeks 1-6. Subjects will be randomized to a controlled eucaloric reduced-CHO (SPEC) or a controlled eucaloric standard (STAN) diet. Subjects will come to UAB two days a week in the morning (Monday-Friday) to be weighed and to collect food for their meals. Energy needs will be estimated by a qualified dietitian using standard equations. All foods for the diet intervention will be provided by the study. Body weight will be recorded to ensure weight maintenance. Energy intake will be adjusted if necessary to maintain body weight. Upon completion, subjects will report to the CRU Outpatient facilities for metabolic testing and WEBB building for body composition assessment. The tests administered are described in the chart below.
One morning, approximately at the midpoint of phase 1, subjects will be asked to come to the CRU and undergo a solid meal test. This test will measure the hormonal and glycemic response to consuming a breakfast that will be provided as a part of the study. The details of this test are outlined below.
Phase 2 Weeks 7-18. Subjects will continue in their assigned diet groups (i.e. SPEC or STAN), but will now receive a controlled hypocaloric diet designed to facilitate weight loss. Subjects will report to UAB two weekday mornings to be weighed and to collect food for their meals. Energy needs will be estimated by a qualified dietitian. All foods for the diet intervention will be provided by the study. Body weight will be recorded two times weekly to monitor weight loss. Upon completion of phase 2, subjects will report to the CRU Outpatient facilities for metabolic testing and the WEBB building for body composition assessment. The tests administered are described in the chart below.
Education and Counseling Sessions At the time of completion of Phase 2, study participants will initiate a series of education and counseling sessions designed to allow them to continue with their assigned diets under a free-living situation for the ensuing 6 weeks. The goal of this phase will be maintenance of the weight loss that occurred during the formal intervention. Subjects will attend group meetings during the 6-week follow-up phase. These meetings will occur weekly during weeks 19-22, and bi-weekly during weeks 23-25. The periodic education and counseling sessions will serve to reinforce the diet guidelines, and to evaluate any problems that have arisen.
Phase 3 Weeks 19-25 subjects will be in a "free-living phase." During weeks 19-25, a dietitian will periodically administer unannounced 24-hour diet recalls by telephone. This involves subjects reporting foods they consumed during the previous day. At the end of Phase 3 subjects will receive a DXA scan and have resting energy expenditure assessed.
- Conditions
- Obesity
- Being tested
- Macronutrient Modification
- Keywords
- puberty, body composition, metabolism, obesity, optimization of body composition, pubertal transition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macronutrient ModificationOther
reduced carbohydrate versus standard carbohydrate diet
| Study group | Role | What they receive |
|---|---|---|
| Reduced Carbohydrate | Active comparator | 42% carbohydrate macronutrient modification Receives: Other: Macronutrient Modification |
| STandard Carbohydrate | Active comparator | 60% carbohydrate macronutrient modification Receives: Other: Macronutrient Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if a hypocaloric (weight-loss), SPEC diet results in greater fat loss than a 12-week, hypocaloric, STAN diet among overweight females aged 7-11 years.
The SPEC diet will be more effective than the STAN diet at promoting fat loss (while preserving bone mass). Evaluate insulin sensitivity, insulin secretion, reproductive hormone status, resting energy expenditure compared to baseline.
Outcomes will be assessed in serum by measurement of insulin/glucose following a liquid meal tolerance test and whole-body body composition bone marrow adipose tissue volume (cm^3); trabecular bone (g) via DXA, MRI, and pQCT, respectively. We will evaluate changes in estradiol (pg/ml), FSH (pg/ml), LH (pg/ml), testosterone (pg/ml) and lipid profile.
Measured: 12-weeks
Secondary outcomes (2)
To evaluate the relationship between genetic factors and the physiologic, hormonal, and metabolic response to the two diets, the genetic admixture and genetic association will be evaluated.
The SPEC diet will be more effective than the STAN diet in decreasing insulin secretion and increasing insulin sensitivity. The SPEC diet will be more effective in reducing insulin, which in turn will reduce estradiol (or the estrogen-androgen ratio) and thereby minimize the relative gain in fat mass.
Evaluate changes in insulin sensitivity, insulin secretion, reproductive hormone concentration, resting energy expenditure and body composition from baseline and compare results between two arms.
Measured: 16 weeks
Determine if a low-carbohydrate diet (SPEC) is more effective than a standard (STAN) diet in decreasing insulin secretion, increasing insulin sensitivity, and decreasing estradiol concentration among overweight girls 7-11 years.
This outcome aims to evaluate metabolic and endocrine changes that occur in the absence of weight change.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2015
- Study completionMar 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 ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Casazza, University of Alabama at Birmingham
- Investigators
- Krista R Casazza, PhD, RD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410643
- Sponsor's protocol ID
- UAB
- Acronym
- PRIMO
- Status last verified
- Nov 2019
- First submitted
- 30 Mar 2011
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanks LJ, Gutierrez OM, Ashraf AP, Casazza K. Bone Mineral Content as a Driver of Energy Expenditure in Prepubertal and Early Pubertal Boys. J Pediatr. 2015 Jun;166(6):1397-403. doi: 10.1016/j.jpeds.2015.02.054. Epub 2015 Apr 1.
PubMed 25841541
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puberty Related Intervention to Improve Metabolic Outcomes (The PRIMO Study)
- ClinicalTrials.gov ID
- NCT01410643
- Acronym / sponsor ID
- PRIMO / UAB
- Conditions
- Obesity
- Keywords
- puberty, body composition, metabolism, obesity, optimization of body composition, pubertal transition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Aug 2011 (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.
Puberty represents a critical period in terms of metabolic health. Racial differences in insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a female's health later in life. Further, the peripubertal period is likely the period of racial divergence in adiposity noted between European American (EA) and African American (AA) girls. Diet is a major modifiable risk factor. The identification of simple, cost-effective dietary strategies for prevention and management of metabolic disease and excess fat mass accrual during the peripubertal period is a priority. Modification of the diet to affect metabolic and endocrine outcomes with and without weight loss during the pubertal transition represents a novel approach to the pediatric obesity epidemic.
It is likely that the two diets used in this project will have different metabolic effects, including effects on postprandial glycemia, triglyceride concentration, free fatty acid concentration, and satiety. These factors may in turn, affect development of metabolic perturbations, especially in susceptible individuals (e.g. AA peripubertal girls).The role of carbohydrates on metabolic outcomes, particularly among children, has received little attention. It has been hypothesized that higher postprandial glycemia may be a mechanism for disease progression. Development of a diet that reduces insulin secretion and optimizes metabolic-endocrine health among peripubertal girls will likely reduce obesity and related co-morbidities and future reliance on pharmacologic treatments, even in the absence of weight loss. However, in light of the current trends in pediatric obesity, a safe and effective regimen that also promotes weight loss is needed for the pediatric population.
This proposal is significant in that it will shed light on whether diet composition, as a part of a eucaloric (weight-stable) or hypocaloric diet (weight-loss) can influence the hyperinsulinemic characteristic of AA peripubertal girls. Existing data suggest that elevated concentrations of insulin and/or reproductive hormones may contribute to the fat mass accrual in AA and could elevate risks for development of chronic diseases in adulthood. The results of this study will lead to the development of dietary means for the reduction of insulin, and thereby to the prevention of both pediatric obesity and type 2 diabetes.
Detailed description
This study will include 100 European and African American girls ages 7-11 years. Subjects must be non-diabetic and overweight (percentile BMI >85th ).
Screening First they will complete a telephone questionnaire regarding medical history and current lifestyle (approximately 15 minutes). If the subject is deemed eligible based on the telephone screening, they will come to UAB for an orientation meeting. At this time the subjects' height and weight will be recorded. They will receive a copy of the study assent/consent form and review the entire protocol with selected study personnel (approximately 60 minutes).
Protocol
Run-In Phase With parental guidance, subjects will complete a 4-day food record for assessment of typical nutrient intake (attached) prior to beginning the run-in diet. The 4-day food record will be analyzed by a registered dietitian using the Minnesota Nutrition Data System. Then subjects will be provided food for 3 days. This diet is similar to the standard "American" diet, and is intended to eliminate inter-subject variance in metabolic outcomes due to free-living dietary factors. The total energy of all diets will be calculated to be eucaloric so that body weight is maintained, and will be determined using the Harris-Benedict equation with an activity factor of 1.35. In previous and ongoing studies at the UAB CRU, this method has resulted in maintenance of body mass. Subjects will come to UAB to be weighed and pick up meals. All meals will be packaged for home consumption. Upon completion of the Run-in Phase, subjects will report to the CRU Outpatient facilities for metabolic testing and WEBB and Boshell buildings for body composition assessment. The tests administered are described below.
Phase 1 Weeks 1-6. Subjects will be randomized to a controlled eucaloric reduced-CHO (SPEC) or a controlled eucaloric standard (STAN) diet. Subjects will come to UAB two days a week in the morning (Monday-Friday) to be weighed and to collect food for their meals. Energy needs will be estimated by a qualified dietitian using standard equations. All foods for the diet intervention will be provided by the study. Body weight will be recorded to ensure weight maintenance. Energy intake will be adjusted if necessary to maintain body weight. Upon completion, subjects will report to the CRU Outpatient facilities for metabolic testing and WEBB building for body composition assessment. The tests administered are described in the chart below.
One morning, approximately at the midpoint of phase 1, subjects will be asked to come to the CRU and undergo a solid meal test. This test will measure the hormonal and glycemic response to consuming a breakfast that will be provided as a part of the study. The details of this test are outlined below.
Phase 2 Weeks 7-18. Subjects will continue in their assigned diet groups (i.e. SPEC or STAN), but will now receive a controlled hypocaloric diet designed to facilitate weight loss. Subjects will report to UAB two weekday mornings to be weighed and to collect food for their meals. Energy needs will be estimated by a qualified dietitian. All foods for the diet intervention will be provided by the study. Body weight will be recorded two times weekly to monitor weight loss. Upon completion of phase 2, subjects will report to the CRU Outpatient facilities for metabolic testing and the WEBB building for body composition assessment. The tests administered are described in the chart below.
Education and Counseling Sessions At the time of completion of Phase 2, study participants will initiate a series of education and counseling sessions designed to allow them to continue with their assigned diets under a free-living situation for the ensuing 6 weeks. The goal of this phase will be maintenance of the weight loss that occurred during the formal intervention. Subjects will attend group meetings during the 6-week follow-up phase. These meetings will occur weekly during weeks 19-22, and bi-weekly during weeks 23-25. The periodic education and counseling sessions will serve to reinforce the diet guidelines, and to evaluate any problems that have arisen.
Phase 3 Weeks 19-25 subjects will be in a "free-living phase." During weeks 19-25, a dietitian will periodically administer unannounced 24-hour diet recalls by telephone. This involves subjects reporting foods they consumed during the previous day. At the end of Phase 3 subjects will receive a DXA scan and have resting energy expenditure assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Carbohydrate | Active comparator | Other: Macronutrient Modification42% carbohydrate macronutrient modification |
| STandard Carbohydrate | Active comparator | Other: Macronutrient Modification60% carbohydrate macronutrient modification |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Self-identified as African American or European American
- Aged 7-11 AND Tanner stage < 3
- Overweight (BMI percentile 85-97th)
- Not taking any medication known to affect body composition
- No prior diagnosis of chronic condition
Key exclusion criteria (5 listed)
- Illness that precludes study participation
- Prescribed medication known to affect body composition
- Not of EA or AA racial/ethnic group
- Obese (BMI% > 97th) or normal weight (BMI% < 85th)
- Reproductively mature as define by Tanner stage > 3
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 |
|---|---|---|
| Macronutrient Modificationreduced carbohydrate versus standard carbohydrate diet | Other | Reduced Carbohydrate, STandard Carbohydrate |
Primary outcome
Determine if a hypocaloric (weight-loss), SPEC diet results in greater fat loss than a 12-week, hypocaloric, STAN diet among overweight females aged 7-11 years.
Time frame: 12-weeks
The SPEC diet will be more effective than the STAN diet at promoting fat loss (while preserving bone mass). Evaluate insulin sensitivity, insulin secretion, reproductive hormone status, resting energy expenditure compared to baseline. Outcomes will be assessed in serum by measurement of insulin/glucose following a liquid meal tolerance test and whole-body body composition bone marrow adipose tissue volume (cm^3); trabecular bone (g) via DXA, MRI, and pQCT, respectively. We will evaluate changes in estradiol (pg/ml), FSH (pg/ml), LH (pg/ml), testosterone (pg/ml) and lipid profile.
2 secondary outcomes
To evaluate the relationship between genetic factors and the physiologic, hormonal, and metabolic response to the two diets, the genetic admixture and genetic association will be evaluated.
Time frame: 16 weeks
Determine if a low-carbohydrate diet (SPEC) is more effective than a standard (STAN) diet in decreasing insulin secretion, increasing insulin sensitivity, and decreasing estradiol concentration among overweight girls 7-11 years.
Time frame: 6-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 25 Nov 2019.
- Derived from this study: PubMed 25841541Hanks LJ, Gutierrez OM, Ashraf AP, Casazza K. Bone Mineral Content as a Driver of Energy Expenditure in Prepubertal and Early Pubertal Boys. J Pediatr. 2015 Jun;166(6):1397-403. doi: 10.1016/j.jpeds.2015.02.054. Epub 2015 Apr 1.
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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.
Krista R Casazza, PhD, RD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macronutrient Modification in people with Obesity, run by University of Alabama at Birmingham 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 5 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 25 Nov 2019. 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?
Determine if a hypocaloric (weight-loss), SPEC diet results in greater fat loss than a 12-week, hypocaloric, STAN diet among overweight females aged 7-11 years. (time frame: 12-weeks). 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 NCT01410643, 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 25 Nov 2019.