Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women

Conditions
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Calcium Deficiency

Intervention / Treatment
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* Behavioral: Receive Kellogg's Nutri-Grain® cereal bars first
* Behavioral: Receive Kellogg's Nutri-Grain® cereal bars second


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Able to speak, read, and understand English Able to consume Kellogg's Nutri-Grain® cereal bars Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Receive cereal bars first<br>This group will receive Kellogg's Nutri-Grain® cereal bars during the second three weeks of the study. | Behavioral: Receive Kellogg's Nutri-Grain® cereal bars first<br>* 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<br>|
| Other: Receive cereal bars second<br>This group will receive Kellogg's Nutri-Grain® cereal bars during the last three weeks of the study. | Behavioral: Receive Kellogg's Nutri-Grain® cereal bars second<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary calcium intake | 1 form of 3-day diet diary per week will be assessed during weeks 2, 6, and 8 of study | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cereal bar, Calcium-fortified, Calcium intake