Effect of Nutrition Bars on Satiety in Women

A Randomized, Controlled, Double-Blind Crossover Pilot Trial to Assess the Effects of Nutrition Bars on Subjective Ratings of Hunger and Fullness in Women

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

Study Overview

• Status: Completed
• Conditions: Hunger; Satiety
• Intervention / Treatment: Other: Nutrition Bar

Detailed Description

Participant eligibility will be screened at visit 1. Test days will commence at 8 to 10 a.m. and visits two to four will be spaced four days apart. On visit days participants consume a nutrition bar; satiety and hunger ratings, blood samples are collected simultaneously over a three hour period. After completion, participants will complete gastrointestinal (GI) tolerability as well as Palatability and Adverse Events questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Glycemic Index Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Extreme dietary habits (e.g. vegan, Atkins diet, exclusion of major food groups, etc.)
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Nutrition bar; 50 g nutrition bar	Other: Nutrition Bar; Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence
Experimental: Nutrition Bar 1; 50 g nutrition bar with additional 2 g of milk-based nutrient	Other: Nutrition Bar; Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence
Experimental: Nutrition bar 2; 50 g nutrition bar with additional 3 g of milk-based nutrient	Other: Nutrition Bar; Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood sample analytes	change in analyte concentrations compared to placebo	3 hour period after consumption of study product, on 3 occasions

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Douglas Bolster, PhD, PepsiCo, Inc.; Principal Investigator: Laura Harkness, PhD, PepsiCo, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2013
• Primary Completion (Actual): May 16, 2014
• Study Completion (Actual): May 16, 2014

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Crossover; Satiety; Hunger; Fullness; Nutrition bar
• Other Study ID Numbers: PEP-1308

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No