Obesity, ChildhoodNCT03139773
Nutrition Intervention to Measure Metabolic Response in Children
A study testing Omega-3 Breakfast Beverage in people with Obesity, Childhood, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial summary
The long-term objective of this study is to determine if habitual consumption of high-quality protein at breakfast will lead to improved energy metabolism and decreased daily energy intake in normal weight and overweight children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Omega-3 Breakfast Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2016to 30 Nov 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Habitual breakfast consumer
- No known medical issues
Who cannot join
- Food allergies
- Medication
- Claustrophobic
- Dietary restrictions
- Picky eater (determined by parent/guardian)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72704
About this study
Official title: Nutrition Intervention to Improve Energy Metabolism, Energy Intake, and Metabolic Response in Overweight and Obese School-aged Children
The long-term objective of this study is to determine if habitual consumption of high-quality protein at breakfast will lead to improved energy metabolism and decreased daily energy intake in normal weight and overweight children. The investigators hypothesize that increasing protein intake at breakfast will improve energy metabolism and reduce energy intake throughout the day in overweight/obese school-aged children. The significance of the study is that improving nutrient intake at breakfast can potentially lead to a future reduction in childhood obesity rates.
- Conditions
- Obesity, Childhood
- Being tested
- Control Breakfast Beverage, Omega-3 Breakfast Beverage
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Breakfast BeverageDietary supplement
Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.
Omega-3 Breakfast BeverageDietary supplement
Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight | Experimental | Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids. Receives: Dietary Supplement: Control Breakfast Beverage; Dietary Supplement: Omega-3 Breakfast Beverage |
| Overweight/Obese | Experimental | Received control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids. Receives: Dietary Supplement: Control Breakfast Beverage; Dietary Supplement: Omega-3 Breakfast Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of breakfast type on energy expenditure four hours postprandial
Energy expenditure will be measured using indirect calorimetry via a TrueMax metabolic cart.
Measured: Change from baseline to four hours postprandial.
The effect of breakfast type on postprandial appetite
Appetite assessment via visual analog scales
Measured: Change from baseline to four hours postprandial.
The effect of breakfast type on appetite hormone secretion
Leptin, adiponectin, PYY, and CCK will be measured using ELISA method.
Measured: Change from baseline to four hours postprandial.
The effect of breakfast type on energy expenditure over 14 days of dietary adaptation.
Whole-body energy expenditure will be measured using doubly-labeled water method
Measured: Fourteen days
Secondary outcomes (3)
Metabolic health measures
Plasma insulin, glucose, lipids
Measured: Baseline and day 14 of each intervention
Gut microbiota
Assessment of gut microbiome
Measured: Baseline and day 14 of each intervention
Proteomic analysis using TMT labeling
Proteomic analysis of baseline samples
Measured: Fasting levels at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start15 May 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Baum, University of Arkansas, Fayetteville
- Investigators
- Jamie I Baum, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139773
- Sponsor's protocol ID
- 15-09-094
- Status last verified
- May 2017
- First submitted
- 8 Mar 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Intervention to Improve Energy Metabolism, Energy Intake, and Metabolic Response in Overweight and Obese School-aged Children
- ClinicalTrials.gov ID
- NCT03139773
- Acronym / sponsor ID
- 15-09-094
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 4 May 2017 (actual)
- 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 long-term objective of this study is to determine if habitual consumption of high-quality protein at breakfast will lead to improved energy metabolism and decreased daily energy intake in normal weight and overweight children. The investigators hypothesize that increasing protein intake at breakfast will improve energy metabolism and reduce energy intake throughout the day in overweight/obese school-aged children. The significance of the study is that improving nutrient intake at breakfast can potentially lead to a future reduction in childhood obesity rates.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Weight | Experimental | Dietary Supplement: Control Breakfast Beverage, Dietary Supplement: Omega-3 Breakfast BeverageReceived control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids. |
| Overweight/Obese | Experimental | Dietary Supplement: Control Breakfast Beverage, Dietary Supplement: Omega-3 Breakfast BeverageReceived control breakfast beverage and breakfast beverage supplemented with omega-3 fatty acids. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Habitual breakfast consumer
- No known medical issues
Key exclusion criteria (5 listed)
- Food allergies
- Medication
- Claustrophobic
- Dietary restrictions
- Picky eater (determined by parent/guardian)
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 |
|---|---|---|
| Control Breakfast BeverageEach participant consumes the breakfast beverage every morning before 10:00 am for 14 days. | Dietary supplement | Normal Weight, Overweight/Obese |
| Omega-3 Breakfast BeverageEach participant consumes the breakfast beverage every morning before 10:00 am for 14 days. | Dietary supplement | Normal Weight, Overweight/Obese |
Primary outcome
The effect of breakfast type on energy expenditure four hours postprandial
Time frame: Change from baseline to four hours postprandial.
Energy expenditure will be measured using indirect calorimetry via a TrueMax metabolic cart.
The effect of breakfast type on postprandial appetite
Time frame: Change from baseline to four hours postprandial.
Appetite assessment via visual analog scales
The effect of breakfast type on appetite hormone secretion
Time frame: Change from baseline to four hours postprandial.
Leptin, adiponectin, PYY, and CCK will be measured using ELISA method.
The effect of breakfast type on energy expenditure over 14 days of dietary adaptation.
Time frame: Fourteen days
Whole-body energy expenditure will be measured using doubly-labeled water method
3 secondary outcomes
Metabolic health measures
Time frame: Baseline and day 14 of each intervention
Gut microbiota
Time frame: Baseline and day 14 of each intervention
Proteomic analysis using TMT labeling
Time frame: Fasting levels at baseline
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 8 May 2017.
- Individual participant dataSharing planned: No
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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.
Jamie I Baum, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Breakfast Beverage in people with Obesity, Childhood, run by University of Arkansas, Fayetteville 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 5 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 8 May 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. 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?
The effect of breakfast type on energy expenditure four hours postprandial (time frame: Change from baseline to four hours postprandial.). The study lists 4 primary outcomes in all. 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 8 May 2017.