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

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

Completed

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Key information

Conditions

Calcium Deficiency

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Receive Kellogg's Nutri-Grain® cereal bars first

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 Kellogg's Nutri-Grain® cereal bars second

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jan 12, 2012
Registry last updated: Feb 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed