Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite

NCT ID: NCT02217124

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-04-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Apple group

twenty four participants will be randomly selected for the apple group, in which they will receive 37.5 grams equal to 120kcal of dried apples twice a day for eight weeks. This snack of apples will be eaten once between breakfast and lunch and once between lunch and dinner and both will be consumed with an eight ounce bottle of water.

Group Type: EXPERIMENTAL

dried apples

Intervention Type: OTHER

120 calories

Muffin control

twenty four participants will be randomly selected to make up the muffin control group, in which one 120kcal muffin control snack will be consumed twice each day for eight weeks. The muffin control will be consumed one between breakfast and lunch and one between lunch and dinner, each snack will be consumed with an eight ounce bottled water.

Group Type: PLACEBO_COMPARATOR

muffin

Intervention Type: OTHER

120 calories

Interventions

dried apples

120 calories

Intervention Type: OTHER

muffin

120 calories

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shirin Hooshmand

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirin Hooshmand, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

San Diego State Univeristy

San Diego, California, United States

Countries

United States

Other Identifiers

S17213

Identifier Type: -

Identifier Source: org_study_id