University of British Columbia
Kelowna, British Columbia, V1V 1V7, Canada
NCT Number: NCT04165707
Very low-carbohydrate ketogenic diet may have beneficial metabolic and weight loss effects, however, adhering to this diet may be challenging. Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote dietary change and weight loss. The purpose of this research is to test the Keyto self-monitoring + app intervention against a "standard of care" weight loss dietary app (Weight Watchers). 144 participants will be recruited through Facebook ads, provide online consent, and will be randomized to one of the two conditions. Weight loss after 12 weeks will be assessed as the primary outcome, with weight loss at 24 and 48 weeks being secondary outcomes. Blood samples will be collected at baseline and 12 weeks with optional blood samples at 48 weeks follow up.
Looking for future studies?
Notify Me18 year–64 year
All sexes
Interventional
Not applicable
Kelowna, British Columbia, V1V 1V7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote a very low carbohydrate diet and weight loss.
The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.
Time frame: 12 weeks from baseline
Change in body mass (in kilograms)
Time frame: 24 and 48 weeks from baseline
Change in body mass (in kilograms)
Time frame: 12, 24, and 48 weeks from baseline
Total consumption of carbohydrates in 24 hour period (in grams)
Time frame: 12, 24, and 48 weeks from baseline
Total consumption of fat in 24 hour period (in grams)
Time frame: 12, 24, and 48 weeks from baseline
Total consumption of saturated fat in 24 hour period (in grams)
Time frame: 12, 24, and 48 weeks from baseline
Total consumption of polyunsaturated fat in 24 hour period (in grams)
Time frame: 12, 24, and 48 weeks from baseline
Total consumption of monounsaturated fat in 24 hour period (in grams)
Time frame: 12, 24, and 48 weeks from baseline
Total energy intake in 24 hour period (in kilocalories)
Time frame: 12 and 48 weeks from baseline
Blood test will be used to determine changes in HbA1C
Time frame: 12 and 48 weeks from baseline
Blood test will be used to determine changes in fasting serum glucose
Time frame: 12 and 48 weeks from baseline
Blood test will be used to determine changes in fasting serum insulin
Time frame: 12 and 48 weeks from baseline
Blood test will be used to determine changes in fasting serum high-sensitivity C-reactive protein
Time frame: 12 and 48 weeks from baseline
Blood test will be used to determine changes in HOMA-IR
Time frame: 12 and 48 weeks from baseline
Blood test will be used to determine changes in serum total cholesterol
Time frame: 12 and 48 weeks from baseline
Blood test will be used to determine changes in serum HDL cholesterol
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum lipoprotein fractions measured by ion mobility
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum lipoprotein (a)
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum trigylcerides
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum non-HDL cholesterol
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum albumin
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum globulin
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum bilirubin
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum alkaline phosphatase
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum aspartate aminotransferase
Time frame: 12 and 48 weeks from baseline
Blood test will determine changes in serum alanine aminotransferase
University of British Columbia
Other
A Randomized Controlled Trial Comparing Weight Loss Effects Between the Keyto Virtual "Ketogenic Diet" Program Compared to a Standard-care Weight Loss App
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.
NCT06124807
Body Weight, Body Weight Changes
Chandler, Arizona, United States
View Trial DetailsNCT05981508
Behavior, Behavior, Animal
Chapel Hill, North Carolina, United States
View Trial DetailsNCT00902694
Body Weight, Body Weight Changes
Baltimore, Maryland, United States
View Trial DetailsNCT06359236
Behavior, Behavior, Animal
Eskişehir, Turkey (Türkiye)
View Trial Details