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Feasibility Testing of Plant-Based Supplemented Food Products Made With Manitoba Crop Ingredients for Weight Loss

15. září 2026 aktualizováno: Dylan MacKay, University of Manitoba

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • Manitoba
      • Winnipeg, Manitoba, Kanada, R2V 3M3
        • Seven Oaks Hospital Chronic Disease Innovation Centre
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Dr Rebecca Mollard, PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: The WLC program plus supplemented food

Participants in weight loss clinic program will consume one supplemented food bar each day and will record this in the product consumption log.

These supplemented foods provide plant-based protein, fibre and fatty acids that have been shown to have health benefits related to chronic disease.

Žádný zásah: The WLC program only

Participants in the weight loss clinic only.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility of incorporating the WI/CDIC supplemented foods into the WI weight loss clinic.
Časové okno: 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.
End of Study (Week 16)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Body Weight
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

Body weight will be measured in kg to the nearest 0.1 kg by an exercise professional.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Waist Circumference
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in BMI
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Cardiovascular Assessment
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes is Quality of Life
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Systolic Blood Pressure
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Diastolic Blood Pressure
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Heart Rate
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Physical Activity
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

Measured using the International Physical Activity Questionnaire - Short Form - (IPAQ-S)

At Enrollment (Week 0) and End of Study (Week 16)
Change in Physical Activity Behaviour Patterns
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake Behaviours
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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)

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake Behaviours
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Number of Meals
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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).

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Number of Snacks
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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).

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Energy
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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).

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Protein
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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).

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Fat
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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).

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Available Carbohydrates
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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).

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Dietary Intake - Fibre
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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).

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Sleep Patterns
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Total Cholesterol
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in High density lipoprotein cholesterol
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Low density lipoprotein cholesterol
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Triglycerides
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Total Cholesterol and High-Density Lipoprotein Cholesterol Ratio
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)
Changes in Hemoglobin A1C
Časové okno: At Enrollment (Week 0) and End of Study (Week 16)

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.

At Enrollment (Week 0) and End of Study (Week 16)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Dr Dylan MacKay, PhD, University of Manitoba

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. listopadu 2026

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

23. září 2024

První předloženo, které splnilo kritéria kontroly kvality

23. září 2024

První zveřejněno (Aktuální)

26. září 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • HS26095 (B2023:073)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

Data will become available following the publication of the primary results manuscript.

Kritéria přístupu pro sdílení IPD

Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the trial PI.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .