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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Texas Woman's University
ClinicalTrials.gov Identifier:
NCT01508689
First received: January 9, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars will increase calcium intake in healthy adult women.


Condition Intervention
Calcium Deficiency
 Behavioral: Receive Kellogg's Nutri-Grain® cereal bars first
Behavioral: Receive Kellogg's Nutri-Grain® cereal bars second

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women

Resource links provided by NLM:

MedlinePlus related topics: Calcium
U.S. FDA Resources

Further study details as provided by Texas Woman's University:

Primary Outcome Measures:
  • Dietary calcium intake [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    1 form of 3-day diet diary per week will be assessed during weeks 2, 6, and 8 of study


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Receive cereal bars first
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
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 cereal bars second
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508689

Locations
United States, Texas
Texas Woman's University
Houston, Texas, United States, 77030
Sponsors and Collaborators
Texas Woman's University
Investigators
Principal Investigator: Jennifer Lee Texas Woman's University
  More Information

No publications provided

Responsible Party: Texas Woman's University
ClinicalTrials.gov Identifier: NCT01508689     History of Changes
Other Study ID Numbers: 16802
Study First Received: January 9, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Woman's University:
Cereal bar
Calcium-fortified
Calcium intake

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013