Effect of Nutrition Bars on Satiety in Women

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

Detailed Description
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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.

Official Title
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A Randomized, Controlled, Double-Blind Crossover Pilot Trial to Assess the Effects of Nutrition Bars on Subjective Ratings of Hunger and Fullness in Women

Conditions
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Hunger, Satiety

Intervention / Treatment
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* Other: Nutrition Bar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Nutrition bar<br>50 g nutrition bar | Other: Nutrition Bar<br>* Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence<br>|
| Experimental: Nutrition Bar 1<br>50 g nutrition bar with additional 2 g of milk-based nutrient | Other: Nutrition Bar<br>* Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence<br>|
| Experimental: Nutrition bar 2<br>50 g nutrition bar with additional 3 g of milk-based nutrient | Other: Nutrition Bar<br>* Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood sample analytes | change in analyte concentrations compared to placebo | 3 hour period after consumption of study product, on 3 occasions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hunger, Fullness, Satiety, Nutrition bar, Crossover