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Completed

NCT Number: NCT04660851

Improving Diet Protein Intake in Middle-aged Women

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Feeding Behavior

Age range

45 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Florida Atlantic University

Boca Raton, Florida, 33431, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Coached

Behavioral

10-weeks of diet coaching weekly by telephone to improve dietary protein intake

Primary outcomes

  1. Changes in dietary protein intake from baseline

    Time frame: 12 weeks

    Assessed changes in dietary protein intake from three 24-hour dietary recalls collected at baseline.

Secondary outcomes

  1. Changes in muscle mass

    Time frame: 12 weeks

    Changes in muscle mass from baseline were measured using bioelectrical impedance analysis

  2. Changes in upper body muscle strength

    Time frame: 12 weeks

    Changes in handgrip strength from baseline were measured using hand dynamometer

  3. Changes in lower body muscle strength and function

    Time frame: 12 weeks

    Changes in 5-chair stand times from baseline were assessed

  4. Changes in muscle function

    Time frame: 12 weeks

    Changes in 4 meter gait speed from baseline were assessed

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2020
Registry last updated
Dec 9, 2020

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.

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