In week 4, we provide participants with a home-based blood ketone-monitoring device (Precision Xtra System; Abbott Diabetes Care, Alameda, California) and ketone strips, which participants use with the device to measure β-hydroxybutyrate (BOHB) in the blood. This method was recently used in a CR diet intervention for individuals with T2DM [39 (link)]. We teach participants how to use the meter in person and ask them to measure their blood ketones before dinner, 2 to 3 times a week, on alternating days. Participants are asked to report ketone results via online survey on a weekly basis. The meters store data, which staff check at every weekly class (starting in week 5) and every monthly class (starting in week 16) to confirm self-reported measurements. Values collected by meters will be used for analysis; however, if their equipment malfunctions (eg, breakage or loss), we will use available self-reported values. For this trial, we define nutritional ketosis as a BOHB level between 0.3 and 3.0 mmol/L. Although the level of carbohydrate restriction needed to achieve ≥0.3 BOHB varies between individuals, in our experience, most individuals need to restrict carbohydrate intake to below 50 g per day of nonfiber carbohydrate to achieve nutritional ketosis.
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