Effect of Nutrition Bars on Satiety in Women

NCT ID: NCT02091570

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-17
• Study Completion Date: 2014-05-16

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.

Conditions

Hunger; Satiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Nutrition bar

50 g nutrition bar

Group Type: PLACEBO_COMPARATOR

Nutrition Bar

Intervention Type: OTHER

Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence

Nutrition Bar 1

50 g nutrition bar with additional 2 g of milk-based nutrient

Group Type: EXPERIMENTAL

Nutrition Bar

Intervention Type: OTHER

Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence

Nutrition bar 2

50 g nutrition bar with additional 3 g of milk-based nutrient

Group Type: EXPERIMENTAL

Nutrition Bar

Intervention Type: OTHER

Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence

Interventions

Nutrition Bar

Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Bolster, PhD

Role: PRINCIPAL_INVESTIGATOR

PepsiCo, Inc.

Laura Harkness, PhD

Role: PRINCIPAL_INVESTIGATOR

PepsiCo, Inc.

Locations

Glycemic Index Laboratories

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29897544 (View on PubMed)

Other Identifiers

PEP-1308

Identifier Type: -

Identifier Source: org_study_id