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

February 17, 2015 updated by: Texas Woman's University
The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars will increase calcium intake in healthy adult women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Woman's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Investigators

  • Principal Investigator: Jennifer Lee, Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 17, 2015

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16802 (University of California, San Francisco)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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