Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors (PowerUp)

NCT00477477 | Terminated

• 2 other identifiers: 07-01-0020K23HL085308
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the efficacy of two diets, a low glycemic load diet and a low saturated fat diet, in the treatment of adolescents with some heart disease risk factors associated with being overweight, such as high blood pressure, pre-diabetes, and cholesterol problems. The objective of the study is to determine which diet improves these risk factors more. The design of the study is a modified feeding study, which requests that the participants eat all and only the food provided by the study for 8 weeks, most days per week. Dietary counseling by phone will continue between 2 and 6 months of the study and the effects of this maintenance period will be assessed at 6 months time.

Conditions

Childhood Obesity; Dyslipidemia; Insulin Resistance; Hypertension

Keywords

overweight; metabolic syndrome; adolescent; cardiovascular; risk factors; hypertension; dyslipidemia; inflammation; coagulopathy

Outcome Measures

Primary Outcomes (1)

• Insulin resistance

  8 weeks, 6 months

Secondary Outcomes (7)

• Inflammation

  8 weeks, 6 months

• dyslipidemia

  8 weeks, 6 months

• blood pressure

  8 weeks, 6 months

• coagulopathy

  8 weeks, 6 months

• vascular function

  8 weeks, 6 months

Study Arms (2)

1

EXPERIMENTAL

Low glycemic load diet

Other: Diet

2

ACTIVE COMPARATOR

Low fat diet

Other: Diet

Interventions

Diet OTHER

Low glycemic load diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.

1

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 8 to 17 years old
• Overweight, defined as BMI ≥ 85th%tile for age and gender
• At least two CV risk factor typical of the metabolic syndrome including insulin resistance, high or borderline blood pressure, low HDL, high TG
• Insulin \> 10 u/L
• Able to attend study visits once a week at participant's home, and eat meals provided by the Children's Hospital CTSA Boston MA as supplied for most meals and snacks
• Non-smoker
• Able to understand/speak English
• Informed consent to participate from a parent or legal guardian. Adolescents must also provide written assent to participate in the study.

You may not qualify if:

• Pre-existing physician diagnosis of a major medical illness or history of a major medical illness including but not limited to heart, kidney or liver disease, cancer, endocrinopathy including thyroid disorder, genetic syndrome or psychiatric illness, also including vasculitides such as Kawasaki disease or rheumatologic disorder; diabetes type I or II, evidence of severe fatty liver, hypertension requiring pharmacologic treatment, history of or current diagnosis of an major eating disorder
• Current or anticipated pregnancy
• Weight more than 275 lbs (125 kg)
• Abnormalities on initial screening assessment requiring pharmacotherapy urgent treatment, such as familial hyperlipidemia, end organ effects of hypertension, or metabolic abnormalities such as diabetes
• Taking any prescription medication or non-prescription substance that affects cholesterol levels, blood pressure, or insulin sensitivity (including but not limited to oral glucocorticoids, oral contraceptives, neuropsychiatric agents, anti-epileptics, HMG-CoA reductase inhibitors, bile acid binding cholesterol transport inhibitors among others) and the use of alcohol or illicit substances.
• Anticipated difficulty with participatory requirements of the study including food allergies, significantly restricted food preferences, or other difficulties as assessed by research staff.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Dyslipidemias; Insulin Resistance; Hypertension; Overweight; Metabolic Syndrome; Inflammation; Hemostatic Disorders

Interventions

Diet

Condition Hierarchy (Ancestors)

Obesity; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sarah D. de Ferranti

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 23, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

US (1)