Clinical trial NCT03134014: High Protein Breakfast on Weight Management and Glycemic Control in 'Breakfast-skipping' Teens
Official title: Long-term Effects of Consuming a High Protein, Beef Breakfast on Weight Management and Glycemic Control in Overweight 'Breakfast-skipping' Young People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breakfast
Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 26
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 75 overweight, habitual 'breakfast-skipping' adolescents will complete the following long-term, randomized controlled trial. Participants will be randomly assigned to the following breakfast treatments: 350 kcal high protein breakfasts containing 30 g protein (primarily from lean beef), 35 g carbohydrates, and 10 g fat; 350 kcal normal protein breakfasts containing 10 g protein, 55 g carbohydrates, and 10 g fat; or will continue to skip breakfast. The following outcomes will be assessed during baseline and 4-month (post-intervention): body weight \& body composition; waist circumference; daily food intake; 24-h free-living glycemic control; and pre and post-prandial satiety. In addition, body weight and free-living breakfast intake (quantity, quality, and type) will also be assessed at 2-month follow-up

Detailed description: The NP and HP groups will be provided with their respective breakfast meals to consume, at home, between 6:00-8:00 am each day over the 4-mo intervention. The energy content of the NP and HP breakfast meals will be standardized to 350 kcal. The energy content of the breakfast meals is \~18% of daily energy intake estimated from the energy expenditure equations specific for adolescents ages 13-16 y. The NP breakfasts will be 11% protein (10 g protein), 63% CHO, and 26% fat, whereas the HP breakfasts will be 34% protein (30 g protein), 40% CHO, and 26% fat. The types of protein incorporated within the NP and HP meals will include a combination of beef (40%), dairy (20%), eggs (20%), and plant-based (20%) proteins. The NP and HP meals will include the same types of breakfasts but will vary in protein and CHO content. An 8-d breakfast rotation will occur throughout the study.

Eligibility criteria: Inclusion Criteria:

1. Males and females
2. All ethnicities
3. Age: 15-21y
4. BMI/BMI Percentile: 20-34.0 kg/m2
5. Never smoked or used other tobacco products
6. Willing to consume the study breakfasts
7. Generally healthy (as assessed by Medical History Questionnaire)

Exclusion Criteria:

1. Clinically diagnosed with an eating disorder
2. Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
3. Currently or previously on a weight loss or other special diet (in the past 6 months)
4. Gained/lost ≥4.5kg over the past 6 months
5. Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)

Primary outcomes:
measure: Body Weight Change
timeFrame: Baseline and 4 months
measure: Body Composition Change
timeFrame: Baseline and 4 months
measure: Energy Intake Change
timeFrame: Baseline and 4 months
measure: 24-h Free-Living Glycemic Control Change
timeFrame: Baseline and 4 months
measure: Sleep Health Change
timeFrame: Baseline and 4 months
measure: Daily Appetite Change
timeFrame: Baseline and 4 months
measure: Food Craving Inventory Change
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Body Weight (2-months post-intervention termination) Change
timeFrame: 5 months and 6 months
measure: Breakfast Intake (2-months post-intervention termination) Change
timeFrame: Average of 3 days at 6 months
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Associate Professor; Clinical Research Center (CTSI) Director
name: Heather Leidy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauer LB, Reynolds LJ, Douglas SM, Kearney ML, Hoertel HA, Shafer RS, Thyfault JP, Leidy HJ. A pilot study examining the effects of consuming a high-protein vs normal-protein breakfast on free-living glycemic control in overweight/obese 'breakfast skipping' adolescents. Int J Obes (Lond). 2015 Sep;39(9):1421-4. doi: 10.1038/ijo.2015.101. Epub 2015 Jun 1.
citation: White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obes Res. 2002 Feb;10(2):107-14. doi: 10.1038/oby.2002.17.