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Effect of Nutrition Bars on Satiety in Women

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ClinicalTrials.gov Identifier: NCT02091570
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : December 17, 2013
Actual Primary Completion Date : May 16, 2014
Actual Study Completion Date : May 16, 2014
Arms and Interventions
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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
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Primary Outcome Measures :
  1. self-reported hunger and fullness rating [ Time Frame: 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 [ Time Frame: 3 hour period after consumption of study product, on 3 occasions ]
    change in analyte concentrations compared to placebo


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091570


Locations
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Canada, Ontario
Glycemic Index Laboratories
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Douglas Bolster, PhD PepsiCo, Inc.
Principal Investigator: Laura Harkness, PhD PepsiCo, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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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