Improving Diet Protein Intake in Middle-aged Women

Dietary Habits Clinical Trial

Official title:

Improving Diet Protein Intake in Middle-aged Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660851
• Other study ID #: 1440147-1
• Status: Completed
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: January 24, 2020

Study information

• Verified date: December 2020
• Source: Florida Atlantic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study sought to examine the effectiveness of nutrition education with and without diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

Description:

The study sought to examine the effectiveness of nutrition education alone and with 10 weeks of diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 64 Years

Eligibility

Inclusion Criteria:

• able to understand and respond to questions or instructions in English
• working telephone
• willingness to consume protein-containing animal products,
• willingness to make changes to the diet

Exclusion Criteria:

• self-reported information that they have been told by a medical doctor that they have kidney (renal) disease
• current or past history of a diagnosed eating disorder
• have an internal cardiac pacemaker/defibrillator or other metal-type implant present
• vegan dietary practices
• refusal to make changes to usual dietary protein intake
• usual dietary protein intake greater than 1.2 g per kg body weight

Related Conditions & MeSH terms

• Dietary Habits

Intervention

Behavioral:
• Coached
10-weeks of diet coaching weekly by telephone to improve dietary protein intake

Locations

Country	Name	City	State
United States	Florida Atlantic University	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Atlantic University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in dietary protein intake from baseline	Assessed changes in dietary protein intake from three 24-hour dietary recalls collected at baseline.	12 weeks
Secondary	Changes in muscle mass	Changes in muscle mass from baseline were measured using bioelectrical impedance analysis	12 weeks
Secondary	Changes in upper body muscle strength	Changes in handgrip strength from baseline were measured using hand dynamometer	12 weeks
Secondary	Changes in lower body muscle strength and function	Changes in 5-chair stand times from baseline were assessed	12 weeks
Secondary	Changes in muscle function	Changes in 4 meter gait speed from baseline were assessed	12 weeks