Effect of Nutrition Bars on Satiety in Women

Satiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091570
• Other study ID #: PEP-1308
• Status: Completed
• Phase: N/A
• Start date: December 17, 2013
• Est. completion date: May 16, 2014

Study information

• Verified date: March 2021
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 16, 2014
• Est. primary completion date: May 16, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported hunger and fullness rating	change in self-reported hunger or fullness compared to placebo	3 hour period after consumption of study product, on 3 occasions
Secondary	blood sample analytes	change in analyte concentrations compared to placebo	3 hour period after consumption of study product, on 3 occasions