Trials / Completed
CompletedNCT03134014
High Protein Breakfast on Weight Management and Glycemic Control in 'Breakfast-skipping' Teens
Long-term Effects of Consuming a High Protein, Beef Breakfast on Weight Management and Glycemic Control in Overweight 'Breakfast-skipping' Young People
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Purdue University · Academic / Other
- Sex
- All
- Age
- 15 Years – 21 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Breakfast | If randomized to a breakfast consuming group, participants will be given breakfasts to consume between 6:00-8:00 am. |
Timeline
- Start date
- 2016-12-12
- Primary completion
- 2018-05-11
- Completion
- 2018-05-11
- First posted
- 2017-04-28
- Last updated
- 2019-05-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03134014. Inclusion in this directory is not an endorsement.