NCT02091570

Brief Summary

This study investigates nutrition bar consumption and possible impact on self-reported ratings of hunger and fullness compared to a control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

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

December 17, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2014

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

March 11, 2014

Last Update Submit

March 8, 2021

Conditions

HungerSatiety

Keywords

HungerFullnessSatietyNutrition barCrossover

Outcome Measures

Primary Outcomes (1)

  • self-reported hunger and fullness rating

    change in self-reported hunger or fullness compared to placebo

    3 hour period after consumption of study product, on 3 occasions

Secondary Outcomes (1)

  • blood sample analytes

    3 hour period after consumption of study product, on 3 occasions

Study Arms (3)

Nutrition bar

PLACEBO COMPARATOR

50 g nutrition bar

Other: Nutrition Bar

Nutrition Bar 1

EXPERIMENTAL

50 g nutrition bar with additional 2 g of milk-based nutrient

Other: Nutrition Bar

Nutrition bar 2

EXPERIMENTAL

50 g nutrition bar with additional 3 g of milk-based nutrient

Other: Nutrition Bar

Interventions

Nutrition BarOTHER

Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence

Nutrition Bar 1Nutrition barNutrition bar 2

Eligibility Criteria

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

You may qualify if:

  • Premenopausal women
  • Body mass index (BMI) 20.00-29.99 kg/m2
  • Maintenance of habitual diet, physical activity patterns, and body weight throughout the trial
  • In general good health on the basis of medical history; and taking no medication other than birth control, hormone replacement therapy, statins or blood pressure medication
  • Participant understands the study procedures, provides signed informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
  • Participant can consume a nutrition bar in the allotted time frame

You may not qualify if:

  • Use of over-the-counter weight-loss drugs and herbal remedies or supplements and dieting programs/behavior (within two months of visit 1)
  • Variation in body weight \>8.8 lbs. (4 kg) within the previous three month before screening
  • Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional
  • Subject scores ≥14 on restraint factor of the Three-Factor Eating Questionnaire
  • History or presence of clinically important renal or gastrointestinal disorders, or diabetes mellitus
  • History of allergy, sensitivity, or strong dislike towards any of the components of the study products
  • Females who are pregnant, or planning to be pregnant during the study period or lactating
  • Use of an investigational drug product within the last 30 days
  • Individual has a condition the Investigator believes would interfere with her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
  • Subject does not understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

  • Bolster DR, Rahn M, Kamil AG, Bristol LT, Goltz SR, Leidy HJ, Blaze Mt M, Nunez MA, Guo E, Wang J, Harkness LS. Consuming Lower-Protein Nutrition Bars with Added Leucine Elicits Postprandial Changes in Appetite Sensations in Healthy Women. J Nutr. 2018 May 1;148(5):693-701. doi: 10.1093/jn/nxy023.

    PMID: 29897544DERIVED

Study Officials

  • Douglas Bolster, PhD

    PepsiCo, Inc.

    PRINCIPAL INVESTIGATOR

  • Laura Harkness, PhD

    PepsiCo, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 19, 2014

Study Start

December 17, 2013

Primary Completion

May 16, 2014

Study Completion

May 16, 2014

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

CA(1)