Feasibility StudiesNCT07142694
Feasibility of Adding a Plant-Based Protein Pudding to the Diet of Older Adults Who Attend a Medically Managed Fitness Facility
A study testing Plant Based pudding in people with Feasibility Studies and Nutrition Intervention, run by Seven Oaks Hospital Chronic Disease Innovation Centre at 1 site in Canada.
Trial summary
The goal of this a 12-week randomized controlled parallel arm feasibility trial is to evaluate the feasibility and acceptability of incorporating a plant-based protein pudding into the diets of older adults who attend a medically managed fitness facility. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feasibility Studies, Nutrition Intervention
- What is being tested?
- Plant Based pudding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial
- Male or female aged ≥60 years
- Actively attend the Wellness Institute (≥8 times in the past 28 days),
Who cannot join
- Allergy to ingredients in the study treatment
- Inability to consume treatment product
- Inability to obtain written informed consent
- Apart of any physical rehab program at WI (cardiac rehab, kidney fit, etc. )
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Chronic Disease Innovation Centre
Winnipeg, Manitoba, R2V 3M3
Navdeep Tangri Tangri, MD,PhD, 204-631-3834, ntangri@sogh.mb.ca
Rebecca Mollard Mollard, PhD, 204-631-3834, rmollard@sogh.mb.ca
About this study
Official title: Evaluation of a Plant-based Protein Pudding In Older Adults Attending a Medically Managed Fitness Facility
The goal of this a 12-week randomized controlled parallel arm feasibility trial is to evaluate the feasibility and acceptability of incorporating a plant-based protein pudding into the diets of older adults who attend a medically managed fitness facility. The primary participant population includes older adults, aged 60 years and above, who are generally healthy and engaged in structured fitness programs.
The main questions it aims to answer are:
Read more
Is a plant-based protein pudding acceptable and well-tolerated by older adults? Does regular consumption of the pudding support muscle health and overall well-being in this population?
Participants will:
Consume a plant-based protein pudding as one arm daily for 7 days per week (experimental) and the other will continue their current lifestyle (control).
The experimental group will complete surveys or questionnaires to assess acceptability, taste, and ease of integration into daily meals.
Undergo basic physical or health assessments (e.g., muscle function or strength evaluations) to evaluate potential effects.
- Conditions
- Feasibility Studies, Nutrition Intervention
- Being tested
- Plant Based pudding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant Based puddingDietary supplement
Will consume one high protein plant based pudding daily for 7-days per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Plant Based Pudding | Experimental | Participants will consume plant based pudding daily for 7 days per week Receives: Dietary Supplement: Plant Based pudding |
| Continue with their current lifestyle | No intervention | Participants will continue with their current lifestyle without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility to Randomization Ratio for Feasibility
A ratio of eligibility to randomization will be collected at 12 months. The trial will be considered feasible if ratio falls within >0.5, calculated as the ratio of individuals who were randomized to the trial to the number eligible to participate who were approached to participate.
Measured: Measured upon study completion after 12-weeks
Recruitment Rate
Recruitment rate will be assessed as the average number of new participants enrolled per site per week during the active recruitment period, with a target of ≥0.5 participants per site per week.
Measured: during 12 months
Follow up rate
Follow-up rate (% of participant outcomes) will be calculated if more than >85% of participant outcomes
Measured: Measured at end of 12 weeks
Adherence to Intervention
Adherence to plant based pudding intervention if more than (75% of dispensed plant based pudding protein is consumed)
Measured: Measured at the end of 12 weeks
Secondary outcomes (13)
Serum Pre-Albumin
Serum albumin is measured in grams per deciliter (g/dL)
Measured: Measured at Baseline Week 1 and at the end of 12 weeks.
Blood Amino Acid Profile
blood amino acid profile
Measured: Measured at Baseline Week 1 and at the end of week 12
Dry Weight
Changes in body weight (Kg)
Measured: Measured at Baseline Week 1 and after the end of week 12
Waist Circumsference
Measured in cm
Measured: Measured at Baseline Week 1 and after the end of week 12
Lean mass
Measured in Kg
Measured: At the baseline week 1 and at end of week 12
Fat Mass
Measured in Kg
Measured: At the baseline week 1 and at end of week 12
Physical function; Five rep chair stand time test
the amount of time it takes for a participant to get up out of a chair five times measured in seconds
Measured: Measured at Baseline Week 1 and after the end of week 12
Blood Pressure
Systolic and Diastolic Blood Pressure Measured in mmHg
Measured: Measured at Baseline Week 1 and after the end of week 12
Total Calories intake
Using RxFoods- Diet recall change in total calories measured in kcal/day
Measured: Measured at Baseline Week 1 and after the end of week 12
Carbohydrates
Measured as g/day
Measured: At the baseline week 1 and at end of week 12
Protein
Measured as g/day
Measured: At the baseline week 1 and at end of week 12
Fat
Measured as g/day
Measured: At the baseline week 1 and at end of week 12
Fiber (total dietary fiber)
Measured as g/day
Measured: At the baseline week 1 and at end of week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Jan 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudiesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a randomized controlled parallel arm feasibility trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seven Oaks Hospital Chronic Disease Innovation Centre
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142694
- Sponsor's protocol ID
- HS26887 (B2025:025)
- Status last verified
- Feb 2026
- First submitted
- 10 Jul 2025
- Last updated
- 5 Feb 2026
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Plant-based Protein Pudding In Older Adults Attending a Medically Managed Fitness Facility
- ClinicalTrials.gov ID
- NCT07142694
- Acronym / sponsor ID
- HS26887 (B2025:025)
- Conditions
- Feasibility Studies, Nutrition Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seven Oaks Hospital Chronic Disease Innovation CentreResearch network
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 27 Aug 2025 (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.
The goal of this a 12-week randomized controlled parallel arm feasibility trial is to evaluate the feasibility and acceptability of incorporating a plant-based protein pudding into the diets of older adults who attend a medically managed fitness facility. The primary participant population includes older adults, aged 60 years and above, who are generally healthy and engaged in structured fitness programs.
The main questions it aims to answer are:
Is a plant-based protein pudding acceptable and well-tolerated by older adults? Does regular consumption of the pudding support muscle health and overall well-being in this population?
Participants will:
Consume a plant-based protein pudding as one arm daily for 7 days per week (experimental) and the other will continue their current lifestyle (control).
The experimental group will complete surveys or questionnaires to assess acceptability, taste, and ease of integration into daily meals.
Undergo basic physical or health assessments (e.g., muscle function or strength evaluations) to evaluate potential effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is a randomized controlled parallel arm feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Plant Based Pudding | Experimental | Dietary Supplement: Plant Based puddingParticipants will consume plant based pudding daily for 7 days per week |
| Continue with their current lifestyle | No intervention | –Participants will continue with their current lifestyle without intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Male or female aged ≥60 years
- Actively attend the Wellness Institute (≥8 times in the past 28 days),
Key exclusion criteria (4 listed)
- Allergy to ingredients in the study treatment
- Inability to consume treatment product
- Inability to obtain written informed consent
- Apart of any physical rehab program at WI (cardiac rehab, kidney fit, etc. )
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 |
|---|---|---|
| Plant Based puddingWill consume one high protein plant based pudding daily for 7-days per week for 12 weeks | Dietary supplement | Plant Based Pudding |
Primary outcome
Eligibility to Randomization Ratio for Feasibility
Time frame: Measured upon study completion after 12-weeks
A ratio of eligibility to randomization will be collected at 12 months. The trial will be considered feasible if ratio falls within >0.5, calculated as the ratio of individuals who were randomized to the trial to the number eligible to participate who were approached to participate.
Recruitment Rate
Time frame: during 12 months
Recruitment rate will be assessed as the average number of new participants enrolled per site per week during the active recruitment period, with a target of ≥0.5 participants per site per week.
Follow up rate
Time frame: Measured at end of 12 weeks
Follow-up rate (% of participant outcomes) will be calculated if more than >85% of participant outcomes
Adherence to Intervention
Time frame: Measured at the end of 12 weeks
Adherence to plant based pudding intervention if more than (75% of dispensed plant based pudding protein is consumed)
13 secondary outcomes
Serum Pre-Albumin
Time frame: Measured at Baseline Week 1 and at the end of 12 weeks.
Blood Amino Acid Profile
Time frame: Measured at Baseline Week 1 and at the end of week 12
Dry Weight
Time frame: Measured at Baseline Week 1 and after the end of week 12
Waist Circumsference
Time frame: Measured at Baseline Week 1 and after the end of week 12
Lean mass
Time frame: At the baseline week 1 and at end of week 12
Fat Mass
Time frame: At the baseline week 1 and at end of week 12
Physical function; Five rep chair stand time test
Time frame: Measured at Baseline Week 1 and after the end of week 12
Blood Pressure
Time frame: Measured at Baseline Week 1 and after the end of week 12
Total Calories intake
Time frame: Measured at Baseline Week 1 and after the end of week 12
Carbohydrates
Time frame: At the baseline week 1 and at end of week 12
Protein
Time frame: At the baseline week 1 and at end of week 12
Fat
Time frame: At the baseline week 1 and at end of week 12
Fiber (total dietary fiber)
Time frame: At the baseline week 1 and at end of week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant Based pudding in people with Feasibility Studies and Nutrition Intervention, run by Seven Oaks Hospital Chronic Disease Innovation Centre at 1 site in Canada.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Feb 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Navdeep Tangri Dr. Tangri, MD, PhD (204-631-3834, NTangri@sogh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility to Randomization Ratio for Feasibility (time frame: Measured upon study completion after 12-weeks). The study lists 4 primary outcomes in all. 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 5 Feb 2026.