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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134014
Other study ID # 1611018501
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2016
Est. completion date May 11, 2018

Study information

Verified date April 2019
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date May 11, 2018
Est. primary completion date May 11, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 21 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (1)

Lead Sponsor Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body Weight Change Body weight will be determined with a standard scale. Baseline and 4 months
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Body Weight (2-months post-intervention termination) Change Body weight will be determined with a standard scale. 5 months and 6 months
Secondary Breakfast Intake (2-months post-intervention termination) Change To assess the participant's energy content at breakfast, all subjects will complete 3 dietary recalls over a 7-day period and an average will of the 3 recalls will occur. 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 breakfast meal. Breakfast energy content will be assessed using the multi-pass system and NDSR (Nutrition Data System for Research). Average of 3 days at 6 months
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