Effect of Nutrition Bars on Satiety in Women

• Sponsor: PepsiCo Global R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02091570
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hunger; Satiety	Other: Nutrition Bar	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Randomized, Controlled, Double-Blind Crossover Pilot Trial to Assess the Effects of Nutrition Bars on Subjective Ratings of Hunger and Fullness in Women
• Actual Study Start Date: Dec 17, 2013
• Actual Primary Completion Date: May 16, 2014
• Actual Study Completion Date: May 16, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. blood sample analytes [3 hour period after consumption of study product, on 3 occasions]

   change in analyte concentrations compared to placebo

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glycemic Index Laboratories	Toronto	Ontario	Canada	M5C 2N8

Sponsors and Collaborators

• PepsiCo Global R&D

Investigators

• Principal Investigator: Douglas Bolster, PhD, PepsiCo, Inc.
• Principal Investigator: Laura Harkness, PhD, PepsiCo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PepsiCo Global R&D
• ClinicalTrials.gov Identifier: NCT02091570
• Other Study ID Numbers: PEP-1308
• First Posted: Mar 19, 2014
• Last Update Posted: Mar 10, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by PepsiCo Global R&D: Hunger; Fullness; Satiety; Nutrition bar; Crossover

Study Results

No Results Posted as of Mar 10, 2021