NCT03595462

Brief Summary

The investigators propose a randomized snack study in normal to overweight adults that will test whether the consumption of different afternoon snacks will have different effects on appetite, mood, blood sugar control, and food intake. Aim 1: To examine whether the addition of hummus as part of an afternoon snack will improve diet quality, particularly through assessments of daily:

  • Vegetable consumption
  • Snacking behavior
  • Energy intake
  • Food choices Aim 2: To examine whether the addition of hummus as part of an afternoon snack will improve appetite control and satiety including assessments of:
  • Appetite Control (hunger, desire to eat, prospective food consumption)
  • Cravings (sweet, salty, savory)
  • Satiety (fullness)
  • Eating initiation Aim 3: To examine whether the addition of hummus as part of an afternoon snack will improve free-living glycemic control. Aim 4: To explore whether the addition of hummus as part of an afternoon snack will improve mood/energy states

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

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

June 8, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

June 30, 2018

Last Update Submit

April 30, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Perceived Hunger

    A questionnaire assessing perceived hunger will be completed at specific times throughout each of the the 6-h testing days. The questionnaire contains a 100 mm 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 range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated. Snacks were consumed at +0 min.

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

  • Perceived Fullness

    A questionnaire assessing perceived fullness will be completed at specific times throughout each of the the 6-h testing days. The questionnaire contains a 100 mm 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 range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated. Snacks were consumed at +0 min.

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

  • Perceived Desire to Eat

    A questionnaire assessing perceived desire to eat will be completed at specific times throughout each of the the 6-h testing days. The questionnaire contains a 100 mm 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 range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated. Snacks were consumed at +0 min.

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

  • Perceived Prospective Food Consumption

    A questionnaire assessing how much food could be consumed will be completed at specific times throughout each of the the 6-h testing days. The questionnaire contains a 100 mm 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 range is 0 mm (min) to 100 (max). A summation (area under the curve) will be calculated. Snacks were consumed at +0 min.

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

Secondary Outcomes (9)

  • Perceived Sweet

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

  • Perceived Salty

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

  • Perceived Savory

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

  • Perceived Sleepiness

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

  • Perceived Energy

    -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min

  • +4 more secondary outcomes

Study Arms (2)

Snack

EXPERIMENTAL

The study participants will be provided with a snack to consume every day of the week. The energy content of the snacks will be standardized to \~240 kcal. The snacks will have different levels of protein, fat, carbohydrates, sugar, and fiber.

Other: Snack

No Snack

PLACEBO COMPARATOR

The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week.

Other: No Snack

Interventions

SnackOTHER

Hummus and Pretzels- The study participants will be provided with a hummus and pretzels snack to consume every day for a week. The energy content of the hummus and pretzels will be \~240 kcal. The hummus and pretzels contain 6 g protein, 27 g carbohydrates, 0 g sugar, 4 g fiber, and 12 g fat. Granola Bars- The study participants will be provided with two granola bars to consume every day for a week. The energy content of the two granola bars will be \~240 kcal. The two granola bars contain 4 g protein, 38 g carbohydrates, 16 g sugar, 2 g fiber, and 9 g fat.

Snack

The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week.

No Snack

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal to overweight (BMI: 18-32 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)
  • non-smoking
  • not been clinically diagnosed with an eating disorder
  • habitually eat an afternoon snack between 2:00-4:00 pm
  • no food allergies related to the study snacks
  • rates the overall liking of hummus higher than "Neither Like nor Dislike" on the screening palatability 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 \>10 lb. 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)
  • Not willing or able to complete all study testing procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Snacks

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Heather J Leidy, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: tightly-controlled, randomized cross-over design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 30, 2018

First Posted

July 23, 2018

Study Start

June 8, 2018

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations