Puberty Related Intervention to Improve Metabolic Outcomes (The PRIMO Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
研究者
Krista Casazza
Assistant Professor
University of Alabama at Birmingham