NCT01781286

Brief Summary

The purpose of this study is to examine the effects of normal vs. protein-rich afternoon snacks on appetite control, satiety, and reward-driven eating (particularly in the evening) in young people. Indices of attention and mood will also be assessed. Study hypotheses include the following:

  1. 1.The consumption of a high-protein, soy-rich afternoon snack will lead to significant improvements in appetite control and satiety, reductions in food motivation and reward, and will delay the drive to eat in normal to overweight young people.
  2. 2.The consumption of a high-protein, soy-rich afternoon snack will lead to reduced unhealthy, evening snacking, particularly on foods high in fat and/or sugar, in normal to overweight young people.
  3. 3.The daily consumption of a high-protein, soy-rich afternoon snack will lead to significant improvements in afternoon alertness, concentration, fatigue, and well-being in normal to overweight young people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 23, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

January 9, 2013

Results QC Date

May 2, 2017

Last Update Submit

July 20, 2018

Conditions

Keywords

ObesitySnackingAppetiteProteinSoyReward driven eatingSatiety

Outcome Measures

Primary Outcomes (1)

  • Time to Dinner Request

    The participants will be asked whether they would like to request a dinner buffet throughout the 5 h post-snack period. When the response is "Yes, I want to eat right now", the time from snack consumption will be recorded.

    1 Day

Secondary Outcomes (5)

  • Appetite Questionnaires

    0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min

  • Snack Palatability and Perception Questionnaires

    5 min

  • Attention & Memory Questionnaires

    90 min

  • Mood-state Questionnaires

    -30 min, +60 min

  • Energy Intake

    +300 min, 24 h

Study Arms (3)

High Protein

ACTIVE COMPARATOR

Higher Protein Soy-based Snacks

Behavioral: High Protein

Low Protein

ACTIVE COMPARATOR

Typical, Low Protein Snacks

Behavioral: Low Protein

No Snack

NO INTERVENTION

No Snack

Interventions

High ProteinBEHAVIORAL

250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat

High Protein
Low ProteinBEHAVIORAL

5% Protein; 50% Carbohydrates; 45% Fat

Low Protein

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age range 13-19 years
  • Normal to overweight (BMI: 50-85th percentile for BMI for age or BMI: 18-29.9 kg/m2)
  • No metabolic, psychological, or neurological diseases/conditions
  • Not currently or previously on a weight loss or other special diet (in the past 6 months)
  • Not clinically diagnosed with an eating disorder
  • Habitually eat (i.e., at least 5 times/week) breakfast between 7:00-9:00 am, lunch between 11:00 am-1:00 pm, an afternoon snack between 2:00-4:00 pm, and dinner
  • No food allergies or intolerances to soy products
  • Rates the overall liking of the study snack foods higher than "Neither Like nor Dislike" on the screening palatability questionnaire
  • Right handed

You may not qualify if:

  • Age 12 years or younger, or 20 years or older
  • Underweight or Obese (below 50th or above 85th percentile for BMI for age, or BMI below 18 or above 29.9 kg/m2)
  • Any metabolic, psychological, or neurological diseases/conditions
  • Currently or previously on a weight loss or other special diet (in the past 6 months)
  • Clinically diagnosed with an eating disorder
  • Does not habitually eat (i.e., at least 5 times/week) breakfast between 7:00-9:00 am, lunch between 11:00 am-1:00 pm, an afternoon snack between 2:00-4:00 pm, and dinner
  • Food allergies or intolerances to soy products
  • Does not rate the overall liking of the study snack foods higher than "Neither Like nor Dislike" on the screening palatability questionnaire
  • Not right handed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

  • Leidy HJ, Todd CB, Zino AZ, Immel JE, Mukherjea R, Shafer RS, Ortinau LC, Braun M. Consuming High-Protein Soy Snacks Affects Appetite Control, Satiety, and Diet Quality in Young People and Influences Select Aspects of Mood and Cognition. J Nutr. 2015 Jul;145(7):1614-22. doi: 10.3945/jn.115.212092. Epub 2015 May 20.

MeSH Terms

Conditions

Obesity

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Limitations and Caveats

Menstrual cycle was not controlled for within the female participants. However, menstrual cyclicity varied between testing days and between participants, thus, reducing any systematic bias/effect.

Results Point of Contact

Title
Dr. Heather Leidy
Organization
University of Missouri

Study Officials

  • Heather J Leidy, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tenure-track Assistant Professor, Heather J Leidy, PhD

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 31, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

July 23, 2018

Results First Posted

July 23, 2018

Record last verified: 2018-07

Locations