Last reviewed · How we verify
NCT03602144
Breakfast and Muscle Health in Children
NA trial testing Carbohydrate in Body Weight Changes in 88 participants. Completed in 31 August 2020.
15 September 2019
Quick facts
| Lead sponsor | University of Arkansas, Fayetteville |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 88 |
| Start date | 21 June 2018 |
| Primary completion | 15 September 2019 |
| Estimated completion | 31 August 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Carbohydrate — full drug profile →
- Protein
Conditions studied
- Body Weight Changes — all drugs for Body Weight Changes →
- Body Composition — all drugs for Body Composition →
- Muscle Mass — all drugs for Muscle Mass →
- Energy Expenditure — all drugs for Energy Expenditure →
Sponsor
University of Arkansas, Fayetteville
Who can join
Adults 7 to 14, any sex, with Body Weight Changes or Body Composition. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
One in every three children ages 2-19 years is overweight or obese. Although multifactorial in nature, obesity is primarily attributed to a mismatch between energy intake and energy expenditure (EE). Daily EE (DEE) can be partitioned between resting metabolic rate (RMR), EE associated with physical activity, and the thermic effect of food (TEF). RMR corresponds to the energy needed to sustain the body functions at rest and is also related to body composition (i.e., ratio of skeletal muscle mass to fat mass). Skeletal muscle mass is a large contributor to RMR; the more skeletal muscle mass, the higher the RMR (i.e., more energy expended at rest). In addition, muscle plays a central role in whole body protein metabolism and disrupted muscle metabolism is associated with the development of many common chronic diseases associated with obesity such as type 2 diabetes and cardiovascular disease. Although the contribution of disrupted muscle metabolism to chronic disease is well-established in older adults, the potential impact in children is unknown. The overall objective for this primary project application is to determine the role of breakfast protein consumption in improving energy metabolism, energy balance and skeletal muscle health in obese, school-aged children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03602144
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Body Weight Changes
Currently open trials in the same condition.
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Other University of Arkansas, Fayetteville trials
Trials by the same sponsor.
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- NCT07490756 — Methods of Assessing Sweat-Electrolyte Testing (MAST) · NA · completed
- NCT06849817 — Protein and Exercise for Postmenopausal Women's Wellbeing · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03602144 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arkansas, Fayetteville
- Last refreshed: 4 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03602144.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing