NCT Number: NCT07142694
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R2V 3M3, Canada
Clara Bohm Bohm, MD
SUB_INVESTIGATOR
Navdeep Tangri Tangri, MD,PhD
CONTACT
Navdeep Tangri Tangri, MD,PhD
PRINCIPAL_INVESTIGATOR
Rebecca Mollard Mollard, PhD
CONTACT
Rebecca Mollard Mollard, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Will consume one high protein plant based pudding daily for 7-days per week for 12 weeks
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.
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.
Time frame: Measured at end of 12 weeks
Follow-up rate (% of participant outcomes) will be calculated if more than >85% of participant outcomes
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)
Time frame: Measured at Baseline Week 1 and at the end of 12 weeks.
Serum albumin is measured in grams per deciliter (g/dL)
Time frame: Measured at Baseline Week 1 and at the end of week 12
blood amino acid profile
Time frame: Measured at Baseline Week 1 and after the end of week 12
Changes in body weight (Kg)
Time frame: Measured at Baseline Week 1 and after the end of week 12
Measured in cm
Time frame: At the baseline week 1 and at end of week 12
Measured in Kg
Time frame: At the baseline week 1 and at end of week 12
Measured in Kg
Time frame: Measured at Baseline Week 1 and after the end of week 12
the amount of time it takes for a participant to get up out of a chair five times measured in seconds
Time frame: Measured at Baseline Week 1 and after the end of week 12
Systolic and Diastolic Blood Pressure Measured in mmHg
Time frame: Measured at Baseline Week 1 and after the end of week 12
Using RxFoods- Diet recall change in total calories measured in kcal/day
Time frame: At the baseline week 1 and at end of week 12
Measured as g/day
Time frame: At the baseline week 1 and at end of week 12
Measured as g/day
Time frame: At the baseline week 1 and at end of week 12
Measured as g/day
Time frame: At the baseline week 1 and at end of week 12
Measured as g/day
Contact information is provided by the study sponsor or research team.
Maryem Zahra, BA
CONTACT
Navdeep Tangri Dr. Tangri, MD, PhD
CONTACT
Seven Oaks Hospital Chronic Disease Innovation Centre
Network
Evaluation of a Plant-based Protein Pudding In Older Adults Attending a Medically Managed Fitness Facility
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07687199
Adolescence, Behavior
Punta Gorda, Toledo District, Belize
View Trial DetailsNCT07266740
Acceptability, Anxiety
Grand Rapids, Michigan, United States
View Trial DetailsNCT07653061
Behavior, Feasibility Studies
Tampere, Finland
View Trial DetailsNCT07589803
Feasibility Studies
Tampere, Finland
View Trial Details