Effect of Nutrition Bars on Satiety in Women

Not Applicable

Completed

• Conditions: Hunger; Satiety
• Interventions: Other: Nutrition Bar

• Registration Number: NCT02091570
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

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

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 Timeline

• Study Start: 2013-12-17
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-19
• Primary Completion: 2014-05-16
• Study Completion: 2014-05-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nutrition bar 2	Nutrition Bar	50 g nutrition bar with additional 3 g of milk-based nutrient
Nutrition bar	Nutrition Bar	50 g nutrition bar
Nutrition Bar 1	Nutrition Bar	50 g nutrition bar with additional 2 g of milk-based nutrient

Primary Outcome Measures

Name	Time	Method
self-reported hunger and fullness rating	3 hour period after consumption of study product, on 3 occasions	change in self-reported hunger or fullness compared to placebo

Secondary Outcome Measures

Name	Time	Method
blood sample analytes	3 hour period after consumption of study product, on 3 occasions	change in analyte concentrations compared to placebo

Trial Locations

Locations (1)

Glycemic Index Laboratories; 🇨🇦 Toronto, Ontario, Canada