Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05919667
Other study ID # MYC_AcuteDairy_2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 2022
Est. completion date March 31, 2023

Study information

Verified date June 2023
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the acute effects of a single serving of dairy and non-dairy alternatives on post-treatment and post-meal glycemia, appetite, plasma amino acid concentrations, and gastrointestinal hormones levels.


Description:

In the past forty years, the prevalence of obesity in adults has doubled with nearly two thirds of Canadian adults currently overweight or obese. The global epidemic of obesity also makes certain individuals more vulnerable to common co-morbidities of obesity, such as type-2-diabetes. To combat these rising numbers, Health Canada released a new Canadian Food Guide (CFG) in 2019. One particular alteration to the new CFG includes dietary guidelines encouraging for an increased consumption of plant-based foods as protein rich sources, shifting away from the promotion of animal-based food products, such as dairy. However, many of the available plant-based substitutes in the market are highly processed with high amounts of sugar, fat, sodium, and additives compared to animal-based products. While literature has shown for plant-based foods to confer numerous health benefits, these are often plant-based foods that have been unprocessed, except for cooking. As the demand for plant-based products continues to grow annually, it is important to assess and compare various obesity and T2D related metabolic outcomes, such as glycemic regulation and appetite control, to better understand the physiological functionality of these products and what role they may or may not play in mitigating the obesity and T2D global epidemics. There is a growing body of evidence from clinical and meta-analysis trials that show dairy products reduce satiety and provide better glycemic control; highlighting their potential to help reduce risk factors associated with obesity and T2D. However, literature has mainly focused on nutrient profile or isolated protein comparatives between animal and plant-based sources. Instead, this study will be looking at comparing dairy products and their plant-based counterparts with respect to their food matrix as a whole, to understand what responses these products produce in the form consumers are naturally eating them by. This study will focus on assessing the metabolic outcomes related to satiety and glycemic regulation. Satiety is an important physiological function related to food intake, and thus, provides a measure to assess reduced obesity risk. Additionally, postprandial glycemic control is an important physiological function that is not only related to the development of type-2 diabetes but also satiety. A total of 16 participants (8 males and 8 females) will participate in this study at the University of Toronto. The study will include a total of 5 sessions over the span of 5 weeks. Prior to the visit, participants will be fasted for 12 hours, excluding water for up to 1 hour before the study visit. During each session, participants will consume a dairy product or a non-dairy plant-based product while subjective appetite, blood glucose, insulin, C-peptide, and gut hormones (ghrelin, GLP-1, GLP-2, and GIP) are obtained post-treatment at 20 min and post a secondary fixed meal of pasta within 15-30 min intervals over a 2 hour timespan. Plasma amino acid concentrations will also be measured within the same timeline outlined above.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 31, 2023
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - BMI: =18.5 kg/m2 and = 24.5 kg/m2' - Fasting serum glucose: = 5.5 mmol/L - Frequent breakfast consumers - Willing to maintain habitual diet, physical activity pattern, dietary supplement routine, and body weight throughout the trial - Willing to abstain from alcohol consumption for 24 h prior to all test visits. - Willing to avoid vigorous physical activity for 24 h prior to all test visits. - Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. Exclusion Criteria: - Fasting blood glucose > 5.5 mmol/L - Smoking tobacco products and marijuana regularly - Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease - Presence of gastrointestinal disorder or surgeries within the past year - Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose, appetite and/or any other outcomes of the study as per investigator's judgment - Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months - Irregular menstrual cycles (i.e., frequent missed cycles), menopausal or post- menopausal - Breakfast skippers - Currently trying to lose or gain weight and any weight gain or loss of at least 10 lbs in previous three months - Known intolerance, sensitivity or allergy to dairy products (including milk and cheese) - Consumption of powders/protein supplements - Extreme dietary habits - Excessive alcohol intake - Restrained Eaters

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dairy and plant-based dairy beverages and solids
Crossover design: participants received all treatment arms in a randomized order

Locations

Country Name City State
Canada Department of Nutritional Sciences, C. David Naylor Building Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in blood glucose level Venous blood collection via catheter Starting at the beginning of each sessions (0 min, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 9 times.
Secondary Subjective appetite Quantifying appetite by using Visual Analogue Scales. Scored 0 to 100
How strong is your desire to eat?
How hungry do you feel?
How full do you feel?
How much food do you think you could eat?
Measured every 15-30 minutes up to 160 minutes]. A total of 9 times.
Secondary Change in plasma metabolic and gut hormones (insulin, c-peptide, glucagon-like 1 receptor, glucagon-like 2 peptide and gastric inhibitory polypeptide) Venous blood collection via catheter Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 7 times.
Secondary Change in plasma amino acid concentrations Venous blood collection via catheter Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 7 times.
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2