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: February 10, 2014
Last verified: February 2014
  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:


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 2014
Estimated Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 10, 2014
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 September 16, 2014