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OpenTrials
Completed

NCT Number: NCT04165707

A Weight Loss RCT Comparing Keyto vs Weight Watchers

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Keyto device + app

Device

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.

Weight Watchers app

Other

The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.

Primary outcomes

  1. Change in body mass at 12 weeks

    Time frame: 12 weeks from baseline

    Change in body mass (in kilograms)

Secondary outcomes

  1. Change in body mass at 24 and 48 weeks

    Time frame: 24 and 48 weeks from baseline

    Change in body mass (in kilograms)

  2. Carbohydrate intake

    Time frame: 12, 24, and 48 weeks from baseline

    Total consumption of carbohydrates in 24 hour period (in grams)

  3. Total fat intake

    Time frame: 12, 24, and 48 weeks from baseline

    Total consumption of fat in 24 hour period (in grams)

  4. Saturated fat intake

    Time frame: 12, 24, and 48 weeks from baseline

    Total consumption of saturated fat in 24 hour period (in grams)

  5. Polyunsaturated fat intake

    Time frame: 12, 24, and 48 weeks from baseline

    Total consumption of polyunsaturated fat in 24 hour period (in grams)

  6. Monounsaturated fat intake

    Time frame: 12, 24, and 48 weeks from baseline

    Total consumption of monounsaturated fat in 24 hour period (in grams)

  7. Total energy intake

    Time frame: 12, 24, and 48 weeks from baseline

    Total energy intake in 24 hour period (in kilocalories)

  8. HbA1C

    Time frame: 12 and 48 weeks from baseline

    Blood test will be used to determine changes in HbA1C

  9. Fasting glucose

    Time frame: 12 and 48 weeks from baseline

    Blood test will be used to determine changes in fasting serum glucose

  10. Fasting insulin

    Time frame: 12 and 48 weeks from baseline

    Blood test will be used to determine changes in fasting serum insulin

  11. Fasting high-sensitivity C-reactive protein

    Time frame: 12 and 48 weeks from baseline

    Blood test will be used to determine changes in fasting serum high-sensitivity C-reactive protein

  12. Fasting homeostasis model assessment of insulin resistance (HOMA-IR)

    Time frame: 12 and 48 weeks from baseline

    Blood test will be used to determine changes in HOMA-IR

  13. Fasting total cholesterol

    Time frame: 12 and 48 weeks from baseline

    Blood test will be used to determine changes in serum total cholesterol

  14. Fasting high-density lipoprotein (HDL) cholesterol

    Time frame: 12 and 48 weeks from baseline

    Blood test will be used to determine changes in serum HDL cholesterol

  15. Fasting lipoprotein fractions

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum lipoprotein fractions measured by ion mobility

  16. Fasting lipoprotein (a)

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum lipoprotein (a)

  17. Fasting triglycerides

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum trigylcerides

  18. Fasting non-HDL cholesterol

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum non-HDL cholesterol

Other outcomes

  1. Fasting albumin

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum albumin

  2. Fasting globulin

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum globulin

  3. Fasting total bilirubin

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum bilirubin

  4. Fasting alkaline phosphatase

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum alkaline phosphatase

  5. Fasting aspartate aminotransferase

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum aspartate aminotransferase

  6. Fasting alanine aminotransferase

    Time frame: 12 and 48 weeks from baseline

    Blood test will determine changes in serum alanine aminotransferase

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Weight Loss Effects Between the Keyto Virtual "Ketogenic Diet" Program Compared to a Standard-care Weight Loss App

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2019
Registry last updated
Aug 26, 2021

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.

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