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Completed

NCT Number: NCT02091570

Effect of Nutrition Bars on Satiety in Women

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories

Toronto, Ontario, M5C 2N8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrition bar

Other

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

Primary outcomes

  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 outcomes

  1. blood sample analytes

    Time frame: 3 hour period after consumption of study product, on 3 occasions

    change in analyte concentrations compared to placebo

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 19, 2014
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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