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

Not Applicable

Completed

• Conditions: Calcium Deficiency
• Interventions: Behavioral: Receive Kellogg's Nutri-Grain® cereal bars first; Behavioral: Receive Kellogg's Nutri-Grain® cereal bars second

• Registration Number: NCT01508689
• Lead Sponsor: Texas Woman's University

Brief 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.

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 Timeline

• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Study Start: 2012-02
• Status Verified: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-02-17
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Age 18 or older
• Able to speak, read, and understand English
• Able to consume Kellogg's Nutri-Grain® cereal bars

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Receive cereal bars first	Receive Kellogg's Nutri-Grain® cereal bars first	This group will receive Kellogg's Nutri-Grain® cereal bars during the second three weeks of the study.
Receive cereal bars second	Receive Kellogg's Nutri-Grain® cereal bars second	This group will receive Kellogg's Nutri-Grain® cereal bars during the last three weeks of the study.

Primary Outcome Measures

Name	Time	Method
Dietary calcium intake	9 weeks	1 form of 3-day diet diary per week will be assessed during weeks 2, 6, and 8 of study

Trial Locations

Locations (1)

Texas Woman's University; 🇺🇸 Houston, Texas, United States