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

NCT03134014 | Completed

• 1 other identifier: 1611018501
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Breakfast; Appetitive Behavior

Outcome Measures

Primary Outcomes (7)

• Body Weight Change

  Body weight will be determined with a standard scale.

  Baseline and 4 months

• Body Composition Change

  Whole body total, fat, and fat free mass will be determined with DXA (GE) within the Bone and Body Composition Core of the Clinical Research Center. The DXA uses a linear X-ray fan beam with switched-pulse dual-energy and a multi-element detector array. The whole body scan takes \<1.8 sec with radiation exposure of 0.01mGy. Waist circumference will be measured using a tape measure by one of the trained study staff members.

  Baseline and 4 months

• Energy Intake Change

  To assess the participant's total energy content all subjects will complete 3 dietary recalls over a 7-day period. The 3 days of data will be averaged together. Trained staff will contact the participant on 3 separate days (over a 7-day period) and ask questions related to the quantity, type, brand, preparation, and timing of food consumed throughout the previous day. Average energy intake will be assessed using the multi-pass system and NDSR (Nutrition Data System for Research). Change in energy intake(assessed as total energy content in kcal) will be determined.

  Baseline and 4 months

• 24-h Free-Living Glycemic Control Change

  Free-living, glucose measures will be performed for 6 consecutive days using the Continuous Glucose Monitoring (CGM; Medtronic; Minneapolis, MN) used in our pilot study (1). The participants will report to our facility during the afternoon (on Day 1) for CGM insertion. A small area on the participant's abdomen will be cleaned and the tiny glucose sensor will be inserted just under the skin and held in place with tegaderm tape. The CGM measures glucose every 10sec and records an average glucose value every 5min for up to 144h. Calibration is performed by 4 finger sticks/d with a glucose analyzer.

  Baseline and 4 months

• Sleep Health Change

  Sleep health will be measured during 7 consecutive days through accelerometry/actigraphy (Actiwatch, Respironics; Philips, Pittsburgh PA). This device will be worn on the wrist, and the participants will continuously wear it over a 7-day period for measures of sleep quality.

  Baseline and 4 months

• Daily Appetite Change

  Questionnaires assessing the appetitive sensations (i.e., hunger, fullness, desire to eat, prospective food consumption), food cravings (sweet, savory-fat, meat), breakfast palatability (i.e., appearance, aroma, flavor, texture, overall liking), and perceived energy (sleepiness, energy, alertness) will be completed every waking hour for 3 days over a 7-day period. The questionnaires contain VAS incorporating a horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely." The questionnaires will be completed on an iPod Touch using an in-house designed application (ScaleKit).

  Baseline and 4 months

• Food Craving Inventory Change

  Participants will fill out a Food Craving Inventory (FCI) questionnaire at baseline and 4-month (post-intervention). The FCI is a reliable and valid self-report measure of general and specific food cravings including cravings for high fat foods, carbohydrates/starches, sweets, and fast food (2). The FCI defines a craving as an intense desire to consume a particular food (or food type) that is difficult to resist. Further, this questionnaire prompts the participant to report how often (never, rarely, sometimes, often, always/almost every hour) he/she experienced a craving for the food throughout the day today.

  Baseline and 4 months

Secondary Outcomes (2)

• Body Weight (2-months post-intervention termination) Change

  5 months and 6 months

• Breakfast Intake (2-months post-intervention termination) Change

  Average of 3 days at 6 months

Study Arms (3)

Breakfast Skipping (BS)

NO INTERVENTION

The BS group will continue to skip breakfast.

Normal Protein Breakfast (NP)

ACTIVE COMPARATOR

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

Dietary Supplement: Breakfast

High Protein Breakfast (HP)

ACTIVE COMPARATOR

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.

Dietary Supplement: Breakfast

Interventions

Breakfast DIETARY_SUPPLEMENT

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

High Protein Breakfast (HP); Normal Protein Breakfast (NP)

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Clinically diagnosed with an eating disorder
• Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
• Currently or previously on a weight loss or other special diet (in the past 6 months)
• Gained/lost ≥4.5kg over the past 6 months
• 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)

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (2)

• 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.

  PMID: 26028058 BACKGROUND

• 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.

  PMID: 11836456 BACKGROUND

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Breakfast

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Heather Leidy, PhD

  Associate Professor; Clinical Research Center (CTSI) Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 28, 2017
• Study Start: December 12, 2016
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)