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

NCT ID: NCT01508689

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-12-31

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.

Conditions

Calcium Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Receive cereal bars first

This group will receive Kellogg's Nutri-Grain® cereal bars during the second three weeks of the study.

Group Type: OTHER

Receive Kellogg's Nutri-Grain® cereal bars first

Intervention Type: BEHAVIORAL

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.

Group Type: OTHER

Receive Kellogg's Nutri-Grain® cereal bars second

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Lee

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

Texas Woman's University

Houston, Texas, United States

Countries

United States

References

Lee JT, Moore CE, Radcliffe JD. Consumption of calcium-fortified cereal bars to improve dietary calcium intake of healthy women: randomized controlled feasibility study. PLoS One. 2015 May 5;10(5):e0125207. doi: 10.1371/journal.pone.0125207. eCollection 2015.

Reference Type: DERIVED

PMID: 25941810 (View on PubMed)

Other Identifiers

16802

Identifier Type: -

Identifier Source: org_study_id