HungerNCT02091570
Effect of Nutrition Bars on Satiety in Women
A study testing Nutrition Bar in people with Hunger and Satiety, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
This study investigates nutrition bar consumption and possible impact on self-reported ratings of hunger and fullness compared to a control. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- Nutrition Bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2013to 16 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
This study investigates nutrition bar consumption and possible impact on self-reported ratings of hunger and fullness compared to a control.
Read the 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.
- Being tested
- Nutrition Bar
- Keywords
- Hunger, Fullness, Satiety, Nutrition bar, Crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition BarOther
Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence
| Study group | Role | What they receive |
|---|---|---|
| Nutrition bar | Placebo comparator | 50 g nutrition bar Receives: Other: Nutrition Bar |
| Nutrition Bar 1 | Experimental | 50 g nutrition bar with additional 2 g of milk-based nutrient Receives: Other: Nutrition Bar |
| Nutrition bar 2 | Experimental | 50 g nutrition bar with additional 3 g of milk-based nutrient Receives: Other: Nutrition Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported hunger and fullness rating
change in self-reported hunger or fullness compared to placebo
Measured: 3 hour period after consumption of study product, on 3 occasions
Secondary outcomes (1)
blood sample analytes
change in analyte concentrations compared to placebo
Measured: 3 hour period after consumption of study product, on 3 occasions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study start17 Dec 2013
- Primary completion16 May 2014
- Study completion16 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HungerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas Bolster, PhD, Principal investigator, PepsiCo, Inc.Laura Harkness, PhD, Principal investigator, PepsiCo, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091570
- Sponsor's protocol ID
- PEP-1308
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2014
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29897544
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02091570
- Acronym / sponsor ID
- PEP-1308
- Keywords
- Hunger, Fullness, Satiety, Nutrition bar, Crossover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2013 (actual)
- Primary completion
- 16 May 2014 (actual)
- Study completion
- 16 May 2014 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutrition bar | Placebo comparator | Other: Nutrition Bar50 g nutrition bar |
| Nutrition Bar 1 | Experimental | Other: Nutrition Bar50 g nutrition bar with additional 2 g of milk-based nutrient |
| Nutrition bar 2 | Experimental | Other: Nutrition Bar50 g nutrition bar with additional 3 g of milk-based nutrient |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition BarIntervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence | Other | Nutrition Bar 1, Nutrition bar, Nutrition bar 2 |
Primary outcome
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
1 secondary outcome
blood sample analytes
Time frame: 3 hour period after consumption of study product, on 3 occasions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 29897544Bolster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Bolster, PhD principal investigator
PepsiCo, Inc.
Laura Harkness, PhD principal investigator
PepsiCo, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Bar in people with Hunger and Satiety, run by PepsiCo Global R&D at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported hunger and fullness rating (time frame: 3 hour period after consumption of study product, on 3 occasions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.