Weight LossNCT06614543
Feasibility Testing of Plant-Based Supplemented Food Products Made With Manitoba Crop Ingredients for Weight Loss
A study testing Supplemented Food in people with Weight Loss, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to advance the development of the WI/CDIC supplemented foods by evaluating the acceptance and feasibility of the supplemented food bars within the Wellness Institute's Weight Loss Clinic program (WLC) or an equivalent weight loss program in Winnipeg or the surrounding area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- Supplemented Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 years or above
- Live within the province of MB
- Ability to give written informed consent in English.
- Enrolled in the Wellness Institute Weight Loss Clinic or an equivalent, approved weight loss program in Winnipeg or the surrounding area.
Who cannot join
- Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
- Participants with known allergies to the supplemented food ingredients
- Has an active eating disorder
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
Seven Oaks Hospital Chronic Disease Innovation Centre
Winnipeg, Manitoba, R2V 3M3
Kathy Cherepak, BSc, 204-631-3834, kcherepak@sogh.mb.ca
Dr Rebecca Mollard, PhD
About this study
The purpose of this study is to advance the development of the WI/CDIC supplemented foods by evaluating the acceptance and feasibility of the supplemented food bars within the Wellness Institute's Weight Loss Clinic program (WLC) or an equivalent weight loss program in Winnipeg or the surrounding area. The main questions it aims to answer are:
- To determine whether the incorporation of WI/CDIC supplemented foods into the WI weight loss clinic design is feasible.
- To determine whether weight loss is supported by a plant-based supplemented food.
- To assess efficacy of the supplemented food by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-supplemented food weight loss program members.
Read more
Researchers will compare the WLC program plus supplemented food to the WLC program without the supplemented food to evaluate the implementation of the supplemented foods into the WLC.
Participants will follow their WLC program for the initial 16 weeks, and those in the intervention group will begin their supplemented food. Participants will consume one supplemented food bar each day and will record this in the product consumption log.
Read the detailed description
This is a pilot evaluation of the feasibility of incorporating the WI/CDIC supplemented food into the WI's newly designed WLC. This study will employ a mixed methods quasi-experimental approach using questionnaires and data collected over the evaluation period. Following consent, participants will be asked to fill out a set of questionnaires, to capture dietary intake, and to wear an activity monitor; to measure diet, physical activity, QOL and sleep before each study meeting. Eligible participants (n=40) will be randomized to intervention (supplemented food) or no intervention. Participants will attend two in-person study visits - one at the initiation and one at the completion of the 16-week weight loss program. Body weight, height, waist circumference, blood pressure and heart rate will be recorded at these two time points as well, as collected through the weight loss clinic program. Participants will also complete an exit questionnaire at the second visit that will include a 9-point hedonic scale to evaluate product acceptability.
- Conditions
- Weight Loss
- Being tested
- Supplemented Food
- Keywords
- Weight Loss Clinic, Supplemented Food
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemented FoodDietary supplement
These supplemented foods provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.
| Study group | Role | What they receive |
|---|---|---|
| The WLC program plus supplemented food | Active comparator | Participants in weight loss clinic program will consume one supplemented food bar each day and will record this in the product consumption log. Receives: Dietary Supplement: Supplemented Food |
| The WLC program only | No intervention | Participants in the weight loss clinic only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of incorporating the WI/CDIC supplemented foods into the WI weight loss clinic.
Feasibility will be demonstrated if the following five criteria are met:
- Eligibility to randomization ratio is greater than 0.5, calculated as the ratio of individuals within the WI WLC program who were randomized to the trial to the number eligible to participate who were approached to participate.
- The percentage of participants who complete the 16-week program in the supplemented food arm is equivalent (plus or minus 10%) or greater than the standard arm.
- Follow up of greater than 85% of participant outcomes.
- Adherence to the supplemented food intervention calculated by consumption of >75% dispensed products as documented in the Product Consumption Log
- Product Acceptability using an Exit Questionnaire consisting of a 9-point hedonic box scale to assess mean acceptability values of 6 or greater (like at least slightly) in 75% or more of the participants.
Measured: End of Study (Week 16)
Secondary outcomes (5)
Changes in Body Weight
Body weight will be measured in kg to the nearest 0.1 kg by an exercise professional.
Measured: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Waist Circumference
Waist circumference in cm will be measured to the nearest 0.1 cm at the umbilicus, between the last rib and iliac crest using a fibreglass tape measured by an exercise professional.
Measured: At Enrollment (Week 0) and End of Study (Week 16)
Changes in BMI
Body Mass Index will be calculated using the formula BMI = kg/m2; where kg is the weight in kilograms and m2 is height in metres squared.
Measured: At Enrollment (Week 0) and End of Study (Week 16)
Cardiovascular Assessment
Using the Framingham Risk Score, cardiovascular risk will be calculated based on age, HDL-C, total cholesterol, systolic blood pressure, smoking status, and diabetes status to determine the participant's 10-year risk of cardiovascular disease and identification of metabolic syndrome.
Measured: At Enrollment (Week 0) and End of Study (Week 16)
Changes is Quality of Life
Quality of life will be measured through the SF-36 quality of life questionnaire. The SF-36 measures nine areas: physical functioning, role functioning (emotional), role functioning (physical), energy/fatigue, emotional well-being, social functioning, pain, general health, and health change. A higher score indicates greater levels of quality of life.
Measured: At Enrollment (Week 0) and End of Study (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed methods
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Seven Oaks Hospital Chronic Disease Innovation Centre, The Wellness Institute, Government of Canada - Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Dylan MacKay, University of Manitoba
- Investigators
- Dr Dylan MacKay, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614543
- Sponsor's protocol ID
- HS26095 (B2023:073)
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) may be placed in a repository if required by a journal for publication purposes. De-identified IPD may also be requested from the principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of Plant-Based Supplemented Food Products Made With Manitoba Crop Ingredients for Weight Loss
- ClinicalTrials.gov ID
- NCT06614543
- Acronym / sponsor ID
- HS26095 (B2023:073)
- Conditions
- Weight Loss
- Keywords
- Weight Loss Clinic, Supplemented Food
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Seven Oaks Hospital Chronic Disease Innovation Centre, The Wellness Institute, Government of Canada - Agriculture and Agri-Food Canada
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Sep 2024 (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 purpose of this study is to advance the development of the WI/CDIC supplemented foods by evaluating the acceptance and feasibility of the supplemented food bars within the Wellness Institute's Weight Loss Clinic program (WLC) or an equivalent weight loss program in Winnipeg or the surrounding area. The main questions it aims to answer are:
- To determine whether the incorporation of WI/CDIC supplemented foods into the WI weight loss clinic design is feasible.
- To determine whether weight loss is supported by a plant-based supplemented food.
- To assess efficacy of the supplemented food by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-supplemented food weight loss program members.
Researchers will compare the WLC program plus supplemented food to the WLC program without the supplemented food to evaluate the implementation of the supplemented foods into the WLC.
Participants will follow their WLC program for the initial 16 weeks, and those in the intervention group will begin their supplemented food. Participants will consume one supplemented food bar each day and will record this in the product consumption log.
Detailed description
This is a pilot evaluation of the feasibility of incorporating the WI/CDIC supplemented food into the WI's newly designed WLC. This study will employ a mixed methods quasi-experimental approach using questionnaires and data collected over the evaluation period. Following consent, participants will be asked to fill out a set of questionnaires, to capture dietary intake, and to wear an activity monitor; to measure diet, physical activity, QOL and sleep before each study meeting. Eligible participants (n=40) will be randomized to intervention (supplemented food) or no intervention. Participants will attend two in-person study visits - one at the initiation and one at the completion of the 16-week weight loss program. Body weight, height, waist circumference, blood pressure and heart rate will be recorded at these two time points as well, as collected through the weight loss clinic program. Participants will also complete an exit questionnaire at the second visit that will include a 9-point hedonic scale to evaluate product acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed methods
| Arm | Type | Receives |
|---|---|---|
| The WLC program plus supplemented food | Active comparator | Dietary Supplement: Supplemented FoodParticipants in weight loss clinic program will consume one supplemented food bar each day and will record this in the product consumption log. |
| The WLC program only | No intervention | –Participants in the weight loss clinic only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18 years or above
- Live within the province of MB
- Ability to give written informed consent in English.
- Enrolled in the Wellness Institute Weight Loss Clinic or an equivalent, approved weight loss program in Winnipeg or the surrounding area.
Key exclusion criteria (3 listed)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
- Participants with known allergies to the supplemented food ingredients
- Has an active eating disorder
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 |
|---|---|---|
| Supplemented FoodThese supplemented foods provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease. | Dietary supplement | The WLC program plus supplemented food |
Primary outcome
Feasibility of incorporating the WI/CDIC supplemented foods into the WI weight loss clinic.
Time frame: End of Study (Week 16)
Feasibility will be demonstrated if the following five criteria are met: 1. Eligibility to randomization ratio is greater than 0.5, calculated as the ratio of individuals within the WI WLC program who were randomized to the trial to the number eligible to participate who were approached to participate. 2. The percentage of participants who complete the 16-week program in the supplemented food arm is equivalent (plus or minus 10%) or greater than the standard arm. 3. Follow up of greater than 85% of participant outcomes. 4. Adherence to the supplemented food intervention calculated by consumption of >75% dispensed products as documented in the Product Consumption Log 5. Product Acceptability using an Exit Questionnaire consisting of a 9-point hedonic box scale to assess mean acceptability values of 6 or greater (like at least slightly) in 75% or more of the participants.
5 secondary outcomes
Changes in Body Weight
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Waist Circumference
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in BMI
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Cardiovascular Assessment
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes is Quality of Life
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) may be placed in a repository if required by a journal for publication purposes. De-identified IPD may also be requested from the principle investigator.
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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.
Dr Dylan MacKay, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemented Food in people with Weight Loss, run by University of Manitoba 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 4 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: opening soon, as of the sponsor's last update on 21 Sep 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 Kathy Cherepak, BSc (204-631-3834, kcherepak@sogh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of incorporating the WI/CDIC supplemented foods into the WI weight loss clinic. (time frame: End of Study (Week 16)). 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 21 Sep 2026.