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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01508689
Enrollment
36
Registered
2012-01-12
Start date
2012-02-29
Completion date
2014-12-31
Last updated
2015-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcium Deficiency

Keywords

Cereal bar, Calcium-fortified, Calcium intake

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.

Interventions

BEHAVIORALReceive 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

BEHAVIORALReceive 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

Sponsors

Texas Woman's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dietary calcium intake9 weeks1 form of 3-day diet diary per week will be assessed during weeks 2, 6, and 8 of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026