Calcium DeficiencyNCT01508689
Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women
A study testing Receive Kellogg's Nutri-Grain® cereal bars first and Receive Kellogg's Nutri-Grain® cereal bars second in people with Calcium Deficiency, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars will increase calcium intake in healthy adult women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Calcium Deficiency
- What is being tested?
- Receive Kellogg's Nutri-Grain® cereal bars first and Receive Kellogg's Nutri-Grain® cereal bars second
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Able to speak, read, and understand English
- Able to consume Kellogg's Nutri-Grain® cereal bars
Who cannot join
- Consumption of calcium supplements or calcium-containing medications
- Regular consumption of 2 Kellogg's Nutri-Grain® cereal bars per month
- Currently pregnant or planning to become pregnant during the course of the study
- Liver disease
- Kidney disease
- Gastrointestinal disease (celiac disease, ulcerative colitis, or Crohn's disease)
Show all 12Show fewer
- Have a history of bariatric surgery
- Had a major cardiovascular event (stroke or myocardial infarction)
- Undergoing treatment of cancer with the exception of non-melanoma cancer
- Following a weight control diet, a disease specific diet, or a vegan diet
- Have a diagnosed eating disorder
- Allergic to any of the ingredients in the study bar
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars will increase calcium intake in healthy adult women.
Read the detailed description
The average intake of calcium in women in the United States from the diet (about 800 mg/day) is below the Recommended Dietary Allowance (1000 mg/day for ages 18 to 50 years, 1200 mg/day for age above 50 years), which increases their risk of developing osteoporosis. Consumption of two calcium-fortified cereal bars per day may be a feasible way to increase the dietary intake of calcium. This study will use Kellogg's Nutri-Grain® cereal bars, which provide 200 mg of calcium per bar, or a total of 400 mg/day.
- Conditions
- Calcium Deficiency
- Being tested
- Receive Kellogg's Nutri-Grain® cereal bars first, Receive Kellogg's Nutri-Grain® cereal bars second
- Keywords
- Cereal bar, Calcium-fortified, Calcium intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive Kellogg's Nutri-Grain® cereal bars firstBehavioural
First three weeks of study: consume perceived usual diet; Second three weeks of study: Receive 42 Kellogg's Nutri-Grain® cereal bars per person, consume 2 bars per day; Third three weeks of study: consume perceived usual diet
Receive Kellogg's Nutri-Grain® cereal bars secondBehavioural
First six weeks of study: consume perceived usual diet; Last three weeks of study: Receive 42 Kellogg's Nutri-Grain® cereal bars per person, consume 2 bars per day
| Study group | Role | What they receive |
|---|---|---|
| Receive cereal bars first | Other | This group will receive Kellogg's Nutri-Grain® cereal bars during the second three weeks of the study. Receives: Behavioral: Receive Kellogg's Nutri-Grain® cereal bars first |
| Receive cereal bars second | Other | This group will receive Kellogg's Nutri-Grain® cereal bars during the last three weeks of the study. Receives: Behavioral: Receive Kellogg's Nutri-Grain® cereal bars second |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary calcium intake
1 form of 3-day diet diary per week will be assessed during weeks 2, 6, and 8 of study
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2014
- Study completionDec 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 Calcium DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Lee, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508689
- Sponsor's protocol ID
- 16802
- Status last verified
- Feb 2014
- First submitted
- 9 Jan 2012
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JT, Moore CE, Radcliffe JD. Consumption of calcium-fortified cereal bars to improve dietary calcium intake of healthy women: randomized controlled feasibility study. PLoS One. 2015 May 5;10(5):e0125207. doi: 10.1371/journal.pone.0125207. eCollection 2015.
PubMed 25941810
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women
- ClinicalTrials.gov ID
- NCT01508689
- Acronym / sponsor ID
- 16802
- Conditions
- Calcium Deficiency
- Keywords
- Cereal bar, Calcium-fortified, Calcium intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jan 2012 (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.
The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars will increase calcium intake in healthy adult women.
Detailed description
The average intake of calcium in women in the United States from the diet (about 800 mg/day) is below the Recommended Dietary Allowance (1000 mg/day for ages 18 to 50 years, 1200 mg/day for age above 50 years), which increases their risk of developing osteoporosis. Consumption of two calcium-fortified cereal bars per day may be a feasible way to increase the dietary intake of calcium. This study will use Kellogg's Nutri-Grain® cereal bars, which provide 200 mg of calcium per bar, or a total of 400 mg/day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive cereal bars first | Other | Behavioral: Receive Kellogg's Nutri-Grain® cereal bars firstThis group will receive Kellogg's Nutri-Grain® cereal bars during the second three weeks of the study. |
| Receive cereal bars second | Other | Behavioral: Receive Kellogg's Nutri-Grain® cereal bars secondThis group will receive Kellogg's Nutri-Grain® cereal bars during the last three weeks of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Able to speak, read, and understand English
- Able to consume Kellogg's Nutri-Grain® cereal bars
Key exclusion criteria (12 listed)
- Consumption of calcium supplements or calcium-containing medications
- Regular consumption of 2 Kellogg's Nutri-Grain® cereal bars per month
- Currently pregnant or planning to become pregnant during the course of the study
- Liver disease
- Kidney disease
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 |
|---|---|---|
| Receive Kellogg's Nutri-Grain® cereal bars firstFirst three weeks of study: consume perceived usual diet; Second three weeks of study: Receive 42 Kellogg's Nutri-Grain® cereal bars per person, consume 2 bars per day; Third three weeks of study: consume perceived usual diet | Behavioural | Receive cereal bars first |
| Receive Kellogg's Nutri-Grain® cereal bars secondFirst six weeks of study: consume perceived usual diet; Last three weeks of study: Receive 42 Kellogg's Nutri-Grain® cereal bars per person, consume 2 bars per day | Behavioural | Receive cereal bars second |
Primary outcome
Dietary calcium intake
Time frame: 9 weeks
1 form of 3-day diet diary per week will be assessed during weeks 2, 6, and 8 of study
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 19 Feb 2015.
- Derived from this study: PubMed 25941810Lee JT, Moore CE, Radcliffe JD. Consumption of calcium-fortified cereal bars to improve dietary calcium intake of healthy women: randomized controlled feasibility study. PLoS One. 2015 May 5;10(5):e0125207. doi: 10.1371/journal.pone.0125207. eCollection 2015.
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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.
Jennifer Lee principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive Kellogg's Nutri-Grain® cereal bars first and Receive Kellogg's Nutri-Grain® cereal bars second in people with Calcium Deficiency, run by Texas Woman's University at 1 site in United States.
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 3 inclusion and 12 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 19 Feb 2015. 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 United States. 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. 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?
Dietary calcium intake (time frame: 9 weeks). 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 NCT01508689, 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 19 Feb 2015.