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

Calcium Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508689
• Other study ID #: 16802
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: February 17, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2014
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Calcium Deficiency

Intervention

Behavioral:
• Receive Kellogg's Nutri-Grain® cereal bars first
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 second
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

Locations

Country	Name	City	State
United States	Texas Woman's University	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No