Clinical trial NCT02217124: Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite
Official title: Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: apple
high fiber
body composition
children
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the proposed research is to determine the influence of 8 weeks of twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat 120kcal muffin on components of obesity (waist circumference \[waist measurement\], serum glucose \[blood sugar\], triglycerides \[fats in the blood\] and HDL-cholesterol, and blood pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight and obese individuals. A total of 48 children aged 10-16 years will be randomly assigned to groups and provided with twice daily 120 kcal servings of either dried apples or muffins for 8 weeks of feeding. Prior to initiating the feeding trial and again after 8 weeks, blood samples will be collected and analyzed. During each visit to the lab, subjects will be weighed in minimal clothing, tested for body composition using dual energy X-ray absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography (Bod Pod) and blood pressure, and measured for waist circumference. One 24-hour recall will be performed prior to initiation of the study; one recall will be performed throughout the feeding period, and one at the end of the 8 weeks. Dietary intake of energy, macronutrients, vitamins and minerals will be assessed to determine diet quality. All food records will be analyzed using the Nutritionist Pro (First DataBank) software. The potential benefits of the study include determining the effects of consistent snacking and particular snack foods on metabolism and weight management. There are no major risks to subjects in this study. There are minimal risks when performing venipuncture (blood draws) including bruising, perforation of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of needles, and infection. This study will hopefully allow more understanding and insight into the diet of children and the effect of it on body makeup and blood sugar. It is hypothesized that the twice a day apple snack group will have decreased waist circumference, body adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at the end of 8 weeks.


Eligibility criteria: Inclusion Criteria:

* must be between age 10-16
* must be overweight or obese according to growth charts

Exclusion Criteria:

* regular consumers of apples (one per day)
* supplement users other than multivitamin

Primary outcomes:
measure: Change from baseline Body Composition at 8 weeks
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change from baseline of triglycerides at 8 weeks
timeFrame: baseline, 8 weeks
measure: Change from baseline blood glucose at 8 weeks
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State Univeristy
state: California
Study officials:
affiliation: San Diego State University
name: Shirin Hooshmand, PhD
role: PRINCIPAL_INVESTIGATOR
References: