Effect of Nutrition Bars on Satiety in Women

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

Tracking Information

• First Submitted Date: March 11, 2014
• First Posted Date: March 19, 2014
• Last Update Posted Date: March 10, 2021
• Actual Study Start Date: December 17, 2013
• Actual Primary Completion Date: May 16, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Nutrition Bars on Satiety in Women
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science

Condition

• Hunger
• Satiety

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 18, 2014): 42
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 16, 2014
• Actual Primary Completion Date: May 16, 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02091570
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: PepsiCo Global R&D
• Original Responsible Party: Same as current
• Current Study Sponsor: PepsiCo Global R&D
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: PepsiCo Global R&D
• Verification Date: March 2021