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

NCT03134014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-05-02

No results posted yet for this study

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

Conditions

  • Breakfast
  • Appetitive Behavior

Interventions

DIETARY_SUPPLEMENT

Breakfast

If randomized to a breakfast consuming group, participants will be given breakfasts to consume between 6:00-8:00 am.

Sponsors & Collaborators

  • Purdue University

    lead OTHER

Principal Investigators

  • Heather Leidy, PhD · Associate Professor; Clinical Research Center (CTSI) Director

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2018-05-11
Completion
2018-05-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03134014 on ClinicalTrials.gov