Puberty Related Intervention to Improve Metabolic Outcomes (The PRIMO Study)

NCT01410643 | Completed

• 1 other identifier: UAB
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Keywords

puberty; body composition; metabolism; obesity; optimization of body composition; pubertal transition

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  6-weeks

Study Arms (2)

Reduced Carbohydrate

ACTIVE COMPARATOR

42% carbohydrate macronutrient modification

Other: Macronutrient Modification

STandard Carbohydrate

ACTIVE COMPARATOR

60% carbohydrate macronutrient modification

Other: Macronutrient Modification

Interventions

Macronutrient Modification OTHER

reduced carbohydrate versus standard carbohydrate diet

Reduced Carbohydrate; STandard Carbohydrate

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 25841541 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Krista R Casazza, PhD, RD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: August 5, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

US (1)