Ketogenic Diet, Overweight and Obesity
Conditions
Keywords
diet, weight loss, ketogenic diet, low carbohydrate
Brief summary
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.
Interventions
DEVICEKeyto device + app
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.
OTHERWeight Watchers app
The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-64 * Living in the State of California * Body mass index (BMI) 27-43 * Must speak, read, and comprehend English * Access to reliable internet and wi-fi * Must have a valid email address and phone number * Must have an Apple iPhone (iPhone 7 or later, iOS 11 or later) with cellular data plan * Must have a kitchen and be willing to cook * Willingness to reduce carbohydrate intake to less than 30g/day * Willingness to restrict intake of added sugar, bread, grain, rice, pasta, sweets, most fruits, pastries, and other carbohydrates * Willingness to comply with a strict diet for 12 months * Willingness to eat a diet that is primarily plant and fish-based * Interest in losing weight
Exclusion criteria
* HIV or immunocompromised * Current or past cancer diagnosis * Pregnant, breastfeeding, or planned pregnancy in next 12 months * Beginning or ending hormonal contraception in next 12 months * Current diagnosis of diabetes * History of heart attack or stent * Currently taking glucose-lowering drugs, statins, or oral steroids * History of gastric bypass surgery or any other weight-loss surgery * History of anorexia or bulimia * History of mental illness * Current smoker or smoked cigarettes within past 12 months * Currently eating fewer than 50 g carbohydrates per day * Have tried a low-carb, high fat (ketogenic diet) within the past 3 months * Recent weight loss or gain of more than 5% body weight in past 6 months * Previous experience with the Weight Watchers diet app * Experience with a low-carbohydrate of ketogenic diet within past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass at 12 weeks | 12 weeks from baseline | Change in body mass (in kilograms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total energy intake | 12, 24, and 48 weeks from baseline | Total energy intake in 24 hour period (in kilocalories) |
| Fasting total cholesterol | 12 and 48 weeks from baseline | Blood test will be used to determine changes in serum total cholesterol |
| Fasting high-density lipoprotein (HDL) cholesterol | 12 and 48 weeks from baseline | Blood test will be used to determine changes in serum HDL cholesterol |
| Fasting lipoprotein fractions | 12 and 48 weeks from baseline | Blood test will determine changes in serum lipoprotein fractions measured by ion mobility |
| Fasting lipoprotein (a) | 12 and 48 weeks from baseline | Blood test will determine changes in serum lipoprotein (a) |
| Fasting triglycerides | 12 and 48 weeks from baseline | Blood test will determine changes in serum trigylcerides |
| Fasting non-HDL cholesterol | 12 and 48 weeks from baseline | Blood test will determine changes in serum non-HDL cholesterol |
| Change in body mass at 24 and 48 weeks | 24 and 48 weeks from baseline | Change in body mass (in kilograms) |
| Carbohydrate intake | 12, 24, and 48 weeks from baseline | Total consumption of carbohydrates in 24 hour period (in grams) |
| Total fat intake | 12, 24, and 48 weeks from baseline | Total consumption of fat in 24 hour period (in grams) |
| Saturated fat intake | 12, 24, and 48 weeks from baseline | Total consumption of saturated fat in 24 hour period (in grams) |
| Polyunsaturated fat intake | 12, 24, and 48 weeks from baseline | Total consumption of polyunsaturated fat in 24 hour period (in grams) |
| Monounsaturated fat intake | 12, 24, and 48 weeks from baseline | Total consumption of monounsaturated fat in 24 hour period (in grams) |
| HbA1C | 12 and 48 weeks from baseline | Blood test will be used to determine changes in HbA1C |
| Fasting glucose | 12 and 48 weeks from baseline | Blood test will be used to determine changes in fasting serum glucose |
| Fasting insulin | 12 and 48 weeks from baseline | Blood test will be used to determine changes in fasting serum insulin |
| Fasting high-sensitivity C-reactive protein | 12 and 48 weeks from baseline | Blood test will be used to determine changes in fasting serum high-sensitivity C-reactive protein |
| Fasting homeostasis model assessment of insulin resistance (HOMA-IR) | 12 and 48 weeks from baseline | Blood test will be used to determine changes in HOMA-IR |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fasting total bilirubin | 12 and 48 weeks from baseline | Blood test will determine changes in serum bilirubin |
| Fasting alkaline phosphatase | 12 and 48 weeks from baseline | Blood test will determine changes in serum alkaline phosphatase |
| Fasting aspartate aminotransferase | 12 and 48 weeks from baseline | Blood test will determine changes in serum aspartate aminotransferase |
| Fasting alanine aminotransferase | 12 and 48 weeks from baseline | Blood test will determine changes in serum alanine aminotransferase |
| Fasting albumin | 12 and 48 weeks from baseline | Blood test will determine changes in serum albumin |
| Fasting globulin | 12 and 48 weeks from baseline | Blood test will determine changes in serum globulin |
Countries
Canada
Outcome results
None listed