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

NCT01508689 | Completed

• 1 other identifier: 16802
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcium Deficiency

Keywords

Cereal bar; Calcium-fortified; Calcium intake

Outcome Measures

Primary Outcomes (1)

• Dietary calcium intake

  1 form of 3-day diet diary per week will be assessed during weeks 2, 6, and 8 of study

  9 weeks

Study Arms (2)

Receive cereal bars first

OTHER

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

Receive cereal bars second

OTHER

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

Interventions

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 cereal bars first

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

Receive cereal bars second

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Able to speak, read, and understand English
• Able to consume Kellogg's Nutri-Grain® cereal bars

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 25941810 DERIVED

Study Officials

• Jennifer Lee

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 12, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 19, 2015

Record last verified: 2014-02

Locations

US (1)