N/A
Completed N=22
The Beneficial Effects of a Protein-rich Breakfast on Appetite Control & Cognition in Overweight and Obese Adolescents
Source: ClinicalTrials.gov NCT01192100 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption — 17000; 11000; 10000; 21000 mm*min
Summary
The purpose of this study is to assess whether the daily addition of a protein-rich breakfast leads to beneficial changes in appetite control, food intake regulation,and cognitive function in overweight & obese 'breakfast skipping' young women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (niAUC) of Perceived Hunger, Fullness, Desire to Eat, and Prospective Food Consumption |
17000; 11000; 10000; 21000; 27000; 28000 | — |
| PRIMARY Area Under the Curve (AUC) of Plasma Total Ghrelin and Ln Peptide YY (PYY) |
41; 35; 34; 0; 90; 160 | — |
| PRIMARY Brain Regions Displaying Differential Activation Prior to Dinner in Response to Food vs Nonfood Stimuli From Food Cue-stimulate fMRI Brain Scans |
-28; -5; -18; -31; -19; -11 | — |
| SECONDARY Daily Energy Intake |
2002; 2292; 2123 | — |
Eligibility Criteria
Inclusion Criteria
The participants must meet the following inclusion criteria:
- Female
- Age range 15-20 y
- Overweight to obese (85th -99th percentile for BMI for age; BMI: 25-39.9 kg/m2
- No metabolic, psychological, or neurological diseases/conditions
- Not currently/previously on a weight loss/other special diet
- Frequently eats lunch ( ≥ 5 eating occasions/wk)
- Consistently skips breakfast every week day (i.e., 5 week days/week)
- Right-handed (necessary for the fMRI analyses)
Exclusion Criteria
The participants will be excluded from participation in the study if they meet the following exclusion criteria:
- Male
- Age >20 y and 40 kg/m2)
- Clinically diagnosed with diabetes (Type I or Type II), having an eating disorder, or having any other metabolic, psychological, or neurological diseases/conditions that would influence the study outcomes.
- Not currently/previously on a weight loss or other special diet (in the past 6 months)
- Skip lunch ( ≥ 2 eating occasions/wk)
- Consume breakfast (≥ 2 eating occasions/wk)
- Left-handed
- Claustrophobic (≥ 2 past bouts of claustrophobia when exposure to small spaces)
- Do not meet the fMRI criteria established by the MU-BIC (regarding metal implants, etc.)
- Pregnant
Data sourced from ClinicalTrials.gov (NCT01192100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.