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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

Tracking Information
First Submitted Date  ICMJE March 11, 2014
First Posted Date  ICMJE March 19, 2014
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE December 17, 2013
Actual Primary Completion Date May 16, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
blood sample analytes [ Time Frame: 3 hour period after consumption of study product, on 3 occasions ]
change in analyte concentrations compared to placebo
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Nutrition Bars on Satiety in Women
Official Title  ICMJE A Randomized, Controlled, Double-Blind Crossover Pilot Trial to Assess the Effects of Nutrition Bars on Subjective Ratings of Hunger and Fullness in Women
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hunger
  • Satiety
Intervention  ICMJE Other: Nutrition Bar
Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence
Study Arms  ICMJE
  • Placebo Comparator: Nutrition bar
    50 g nutrition bar
    Intervention: Other: Nutrition Bar
  • Experimental: Nutrition Bar 1
    50 g nutrition bar with additional 2 g of milk-based nutrient
    Intervention: Other: Nutrition Bar
  • Experimental: Nutrition bar 2
    50 g nutrition bar with additional 3 g of milk-based nutrient
    Intervention: Other: Nutrition Bar
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2014)
42
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 16, 2014
Actual Primary Completion Date May 16, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02091570
Other Study ID Numbers  ICMJE PEP-1308
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party PepsiCo Global R&D
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PepsiCo Global R&D
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas Bolster, PhD PepsiCo, Inc.
Principal Investigator: Laura Harkness, PhD PepsiCo, Inc.
PRS Account PepsiCo Global R&D
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP