Effect of Nutrition Bars on Satiety in Women

PepsiCo

Status: Completed

Conditions: Satiety; Hunger

Treatments: Other: Nutrition Bar

Study type: Interventional

Funder types: Industry

Identifiers

NCT02091570

PEP-1308

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 3 patient groups, including a placebo group

Nutrition bar

Placebo Comparator group

Description:

50 g nutrition bar

Treatment:

Other: Nutrition Bar

Nutrition Bar 1

Experimental group

Description:

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

Treatment:

Other: Nutrition Bar

Nutrition bar 2

Experimental group

Description:

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

Treatment:

Other: Nutrition Bar