HealthyNCT04378556
Improving Dietary Protein Intake in Adults
A study testing Nutritional coaching in people with Healthy, run by Florida Atlantic University at 1 site in United States.
Trial summary
A pilot, single-arm investigation used coaching, nutrition education, and a per-meal protein prescription to assess impact on protein intake, muscle strength and function in older adults. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nutritional coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 55 years or older,
- Community-dwelling (living independently),
- Able to provide consent,
- Able to understand and respond to questions or instructions in English,
- Have a working telephone (for coaching sessions),
- Willingness to consume protein-containing animal products
- Willingness to make changes to the diet
Who cannot join
- Self-reported information that they have been told by a medical doctor that they have kidney (renal) disease.
- Vegan dietary practices,
- Refusal to make changes to usual dietary protein intake, or a usual dietary protein intake that meets recommendations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Atlantic University
Boca Raton, Florida, 33431
About this study
A pilot, single-arm investigation used coaching, nutrition education, and a per-meal protein prescription to assess impact on protein intake, muscle strength and function in older adults.
Read the detailed description
Objective: To evaluate the effects of nutrition education, diet coaching, and a protein prescription (PP) on protein intake, and associations with muscle strength and function. Design: Prospective pretest posttest single-arm study. Setting: Urban area, East coast of South Florida. Participants: Older adults. Intervention: 10-week telephone-based diet coaching, nutrition education and a per-meal PP. Measurements: Protein and energy intakes, weight, grip strength (GS), and 5-chair-rise (5CR), timed up and go (TUG), 3-meter walk (3mW) tests at baseline and 10 weeks.
- Conditions
- Healthy
- Being tested
- Nutritional coaching
- Keywords
- Protein intake, Coaching, Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional coachingBehavioural
Participants were provided with nutrition education and a per-meal protein prescription followed by 9 weeks of nutritional coaching.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition | Other | All participants received diet coaching, nutrition education and a per-meal protein prescription. Receives: Behavioral: Nutritional coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Protein intake
Protein intake (g/kg/body weight) per day
Measured: Change from baseline to 10 weeks
Secondary outcomes (5)
Change in Grip strength
Grip strength measured using dynamometer
Measured: Change from baseline to 10 weeks
Change in Timed Up and Go Test
The timed up and go test measures the time (in seconds) that it takes to stand up from a seated position in a chair, walk 3 meters away from the chair at a comfortable pace to a line on the floor, turn around, walk back, and sit back down in the chair.
Measured: Change from baseline to 10 weeks
Change in 3 meter walk
The 3-meter walk test measures the time (in seconds) that it takes to stand up from a seated position in a chair and walk 3 meters away from the chair at a comfortable pace to a line on the floor
Measured: Change from baseline to 10 weeks
Change in 5-Chair Rise Stand Test
The 5 chair rise stand test requires participants to stand up 5 times without hand assistance from a straight back chair without an armrest. The time required to complete the 5 chair rises is recorded.
Measured: Change from baseline to 10 weeks
Change in Short Performance Physical Battery Score
The Short Physical Performance Battery (SPPB) consists of timed measures of balance, 3-meter walk, and 5-chair rises. The balance portion requires participants to stand with feet next to each other, the toes of one foot next to the heel of the other foot, and heel to toe for a 10 second duration. Scores are assigned based on the number of seconds the participant can stand in the position for balance. Scores for the chair rise and 3 meter walk are based on the time taken to complete the task. The scores are totaled to arrive at the Short Performance Physical Battery Score
Measured: Change from baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start4 Jun 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures design
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378556
- Sponsor's protocol ID
- 1151456-1
- Status last verified
- May 2020
- First submitted
- 27 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Dietary Protein Intake in Adults
- ClinicalTrials.gov ID
- NCT04378556
- Acronym / sponsor ID
- 1151456-1
- Conditions
- Healthy
- Keywords
- Protein intake, Coaching, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot, single-arm investigation used coaching, nutrition education, and a per-meal protein prescription to assess impact on protein intake, muscle strength and function in older adults.
Detailed description
Objective: To evaluate the effects of nutrition education, diet coaching, and a protein prescription (PP) on protein intake, and associations with muscle strength and function. Design: Prospective pretest posttest single-arm study. Setting: Urban area, East coast of South Florida. Participants: Older adults. Intervention: 10-week telephone-based diet coaching, nutrition education and a per-meal PP. Measurements: Protein and energy intakes, weight, grip strength (GS), and 5-chair-rise (5CR), timed up and go (TUG), 3-meter walk (3mW) tests at baseline and 10 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Nutrition | Other | Behavioral: Nutritional coachingAll participants received diet coaching, nutrition education and a per-meal protein prescription. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 55 years or older,
- Community-dwelling (living independently),
- Able to provide consent,
- Able to understand and respond to questions or instructions in English,
- Have a working telephone (for coaching sessions),
Key exclusion criteria (3 listed)
- Self-reported information that they have been told by a medical doctor that they have kidney (renal) disease.
- Vegan dietary practices,
- Refusal to make changes to usual dietary protein intake, or a usual dietary protein intake that meets recommendations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional coachingParticipants were provided with nutrition education and a per-meal protein prescription followed by 9 weeks of nutritional coaching. | Behavioural | Nutrition |
Primary outcome
Change in Protein intake
Time frame: Change from baseline to 10 weeks
Protein intake (g/kg/body weight) per day
5 secondary outcomes
Change in Grip strength
Time frame: Change from baseline to 10 weeks
Change in Timed Up and Go Test
Time frame: Change from baseline to 10 weeks
Change in 3 meter walk
Time frame: Change from baseline to 10 weeks
Change in 5-Chair Rise Stand Test
Time frame: Change from baseline to 10 weeks
Change in Short Performance Physical Battery Score
Time frame: Change from baseline to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional coaching in people with Healthy, run by Florida Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Protein intake (time frame: Change from baseline to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.