An interventional study of Supplemented Food in Weight Loss, sponsored by University of Manitoba. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
Among 67 studies in Weight Loss with a site in Canada — 14 open to participants now, 18 under way, 1 of them phase 3. Weight Loss · Canada.
Among the 67 studies in Weight Loss with a site in Canada, this one is the 40th largest by planned enrollment of the 60 interventional ones that give a count, is one of 5 that started in 2026, is one of 36 with no phase, reaches primary completion later than 10 of the 17 other live ones, and was the 56th registered.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
Browse Weight Loss studies →14 of the 67 studies in Weight Loss with a site in Canada are open now. Recruiting first, the newest first:
McMaster University · Sites in Canada
Alain Dagher · Sites in Canada
Pfizer · Sites in Canada, United States, Australia and 18 more countries
McMaster University · Sites in Canada
Endevica Bio · Sites in Canada, United States
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
67 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 10 · Phase 3 6 · Phase 4 8
First in 2001; this study’s year is marked. 5 started in 2026.
This study's planned enrollment of 40 is below the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Median enrollment 67 across the 60 interventional studies, 100 across the 7 observational. Of the 38 that completed or were terminated, 4 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 67 have an industry lead sponsor. The 10 most frequent:
University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
University of Manitoba has 2 studies filed under Weight Loss — fewer than ten, so there is no comparison to draw.
3 of the studies in Weight Loss with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06151964AstraZenecaA Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight | 2027-01-29 |
| NCT07685834Sofwave Medical LTDEvaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight Loss | 2027-03-01 |
| NCT06937177Endevica BioSafely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy | 2027-10 |
Among the 67 studies in Weight Loss with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in weight loss clinic program will consume one supplemented food bar each day and will record this in the product consumption log.
Dietary Supplement: Supplemented Food
Participants in the weight loss clinic only.
These supplemented foods provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.
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: 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.
Time frame: End of Study (Week 16)
Changes in Body Weight
Body weight will be measured in kg to the nearest 0.1 kg by an exercise professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Systolic Blood Pressure
Systolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Diastolic Blood Pressure
Diastolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Heart Rate
Heart rate in beats per minute is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Physical Activity
Measured using the International Physical Activity Questionnaire - Short Form - (IPAQ-S)
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Change in Physical Activity Behaviour Patterns
Assessed using total active minutes per day as measured by multi-directional accelerometry for 7 days. Participants will be asked to wear the accelerometer at all times.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake Behaviours
Dietary intake behaviours will be measured through The Mindful Eating Questionnaire. The Mindful Eating Questionnaire recognizing patterns of overeating or eating in response to stress, boredom, or other emotions. Scoring is based on five categories, which include Awareness (being aware of how food looks, tastes and smells); Distraction (focusing on other things while eating); Disinhibition (eating even when full); Emotional Response (eating in response to sadness or stress); and External Cues (eating in response to environmental cues, such as advertising)
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake Behaviours
Changes in dietary intake behaviours will be measured through the Three Factor Eating Questionnaire which is comprised of 18 items, measuring uncontrolled eating, restrained eating and emotional eating. The higher the score represents more dependency to cognition, stress or emotion the eating patterns.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Number of Meals
Number of meals will be captured with a meal being defined as food intake greater than 500 kcal. Dietary intake will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Number of Snacks
Number of snacks will be captured with a meal being defined as food intake less than 500 kcal. Dietary intake will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Energy
Energy will be measured in kCals and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Protein
Protein will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Fat
Fat will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Available Carbohydrates
Available carbohydrates will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Fibre
Fibre will be measured in grams and will be captured using the RxFood app. RxFood is a type of AI-driven, image based dietary assessment tool that has already demonstrated clinical benefits in various adult and pediatric clinical settings and in research as a data collection tool. Strong correlation and strength of agreement have been illustrated between RxFood and nutrient estimates from Esha's Research Nutrition analysis software, which is an industry choice for nutritional analysis and regulatory compliance (Jefferson et al, 2020).
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Sleep Patterns
An ActiGraph activity monitor will be used to measure sleep quality patterns for 7 days, with participants asked to wear the monitor at all times, including when they sleep.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Total Cholesterol
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in High density lipoprotein cholesterol
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Low density lipoprotein cholesterol
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Triglycerides
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Total Cholesterol and High-Density Lipoprotein Cholesterol Ratio
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Changes in Hemoglobin A1C
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.
Time frame: At Enrollment (Week 0) and End of Study (Week 16)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available following the publication of the primary results manuscript.
Access criteria: Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the trial PI.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 670 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 13 months is below that.
Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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