A Randomized Controlled Trial Comparing Weight Loss Effects Between the Keyto Virtual "Ketogenic Diet" Program Compared to a Standard-care Weight Loss App
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- Change in body mass at 12 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Keyto intervention arm
Keyto device + app
Intervention: Keyto device + app (Device)
Weight Watchers comparator arm
Weight Watchers app
Intervention: Weight Watchers app (Other)
Outcomes
Primary Outcomes
Change in body mass at 12 weeks
Time Frame: 12 weeks from baseline
Change in body mass (in kilograms)
Secondary Outcomes
- Fasting insulin(12 and 48 weeks from baseline)
- Fasting high-sensitivity C-reactive protein(12 and 48 weeks from baseline)
- Fasting homeostasis model assessment of insulin resistance (HOMA-IR)(12 and 48 weeks from baseline)
- Fasting total cholesterol(12 and 48 weeks from baseline)
- Fasting high-density lipoprotein (HDL) cholesterol(12 and 48 weeks from baseline)
- Fasting lipoprotein fractions(12 and 48 weeks from baseline)
- Fasting lipoprotein (a)(12 and 48 weeks from baseline)
- Fasting triglycerides(12 and 48 weeks from baseline)
- Fasting non-HDL cholesterol(12 and 48 weeks from baseline)
- Change in body mass at 24 and 48 weeks(24 and 48 weeks from baseline)
- Carbohydrate intake(12, 24, and 48 weeks from baseline)
- Total fat intake(12, 24, and 48 weeks from baseline)
- Saturated fat intake(12, 24, and 48 weeks from baseline)
- Polyunsaturated fat intake(12, 24, and 48 weeks from baseline)
- Monounsaturated fat intake(12, 24, and 48 weeks from baseline)
- Total energy intake(12, 24, and 48 weeks from baseline)
- HbA1C(12 and 48 weeks from baseline)
- Fasting glucose(12 and 48 weeks from baseline)
Investigators
Jonathan Little
Assistant Professor
University of British Columbia