High Protein Breakfast on Weight Management and Glycemic Control in 'Breakfast-skipping' Teens

Purdue University

Status: Completed

Conditions: Appetitive Behavior; Breakfast

Treatments: Dietary Supplement: Breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT03134014

1611018501

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 15 to 21 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 3 patient groups

Breakfast Skipping (BS)

No Intervention group

Description:

The BS group will continue to skip breakfast.

Normal Protein Breakfast (NP)

Active Comparator group

Description:

The NP groups will be provided with the 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 breakfast meals will be standardized to 350 kcal. The NP breakfasts will be 11% protein (10 g protein), 63% CHO, and 26% fat

Treatment:

Dietary Supplement: Breakfast

High Protein Breakfast (HP)

Active Comparator group

Description:

The HP group will be provided with the 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 breakfast meals will be standardized to 350 kcal. The HP breakfasts will be 34% protein (30 g protein), 40% CHO, and 26% fat.

Treatment:

Dietary Supplement: Breakfast