ObesityNCT02217124
Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite
A study testing dried apples and muffin in people with Obesity, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- dried apples and muffin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- must be between age 10-16
- must be overweight or obese according to growth charts
Who cannot join
- regular consumers of apples (one per day)
- supplement users other than multivitamin
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State Univeristy
San Diego, California, 92182
About this study
Official title: Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite in Children
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
- Being tested
- dried apples, muffin
- Keywords
- apple, high fiber, body composition, children
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dried applesOther
120 calories
muffinOther
120 calories
| Study group | Role | What they receive |
|---|---|---|
| Apple group | Experimental | 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. Receives: Other: dried apples |
| Muffin control | Placebo comparator | 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. Receives: Other: muffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Body Composition at 8 weeks
Height, Weight, waist circumference, Body Mass Index are all used to asses body composition. Bod pod, BIA, and Dexa are also used to obtain the body composition.
Measured: baseline, 8 weeks
Secondary outcomes (2)
Change from baseline of triglycerides at 8 weeks
Measured: baseline, 8 weeks
Change from baseline blood glucose at 8 weeks
Used to examine glucose regulation as effected by the apple group intervention.
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shirin Hooshmand, San Diego State University
- Investigators
- Shirin Hooshmand, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217124
- Sponsor's protocol ID
- S17213
- Status last verified
- Aug 2017
- First submitted
- 12 Aug 2014
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite in Children
- ClinicalTrials.gov ID
- NCT02217124
- Acronym / sponsor ID
- S17213
- Conditions
- Obesity
- Keywords
- apple, high fiber, body composition, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple group | Experimental | Other: dried applestwenty 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. |
| Muffin control | Placebo comparator | Other: muffintwenty 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- must be between age 10-16
- must be overweight or obese according to growth charts
Key exclusion criteria (2 listed)
- regular consumers of apples (one per day)
- supplement users other than multivitamin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dried apples120 calories | Other | Apple group |
| muffin120 calories | Other | Muffin control |
Primary outcome
Change from baseline Body Composition at 8 weeks
Time frame: baseline, 8 weeks
Height, Weight, waist circumference, Body Mass Index are all used to asses body composition. Bod pod, BIA, and Dexa are also used to obtain the body composition.
2 secondary outcomes
Change from baseline of triglycerides at 8 weeks
Time frame: baseline, 8 weeks
Change from baseline blood glucose at 8 weeks
Time frame: baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirin Hooshmand, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dried apples and muffin in people with Obesity, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Body Composition at 8 weeks (time frame: baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.