An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial

Abstract

BackgroundType 2 diabetes is a prevalent, chronic disease for which diet is an integral aspect of treatment. In our previous trial, we found that recommendations to follow a very low-carbohydrate ketogenic diet and to change lifestyle factors (physical activity, sleep, positive affect, mindfulness) helped overweight people with type 2 diabetes or prediabetes improve glycemic control and lose weight. This was an in-person intervention, which could be a barrier for people without the time, flexibility, transportation, social support, and/or financial resources to attend.ObjectiveThe aim was to determine whether an online intervention based on our previous recommendations (an ad libitum very low-carbohydrate ketogenic diet with lifestyle factors; “intervention”) or an online diet program based on the American Diabetes Associations’ “Create Your Plate” diet (“control”) would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes.MethodsIn this pilot feasibility study, we randomized overweight adults (body mass index ≥25) with type 2 diabetes (glycated hemoglobin [HbA1c] 6.5%-9.0%) to a 32-week online intervention based on our previous recommendations (n=12) or an online diet program based around a plate method diet (n=13) to assess the impact of each intervention on glycemic control and other health outcomes. Primary and secondary outcomes were analyzed by mixed-effects linear regression to compare outcomes by group.ResultsAt 32 weeks, participants in the intervention group reduced their HbA1c levels more (estimated marginal mean [EMM] –0.8%, 95% CI –1.1% to –0.6%) than participants in the control group (EMM –0.3%, 95% CI –0.6% to 0.0%; P=.002). More than half of the participants in the intervention group (6/11, 55%) lowered their HbA1c to less than 6.5% versus 0% (0/8) in the control group (P=.02). Participants in the intervention group lost more weight (EMM –12.7 kg, 95% CI –16.1 to –9.2 kg) than participants in the control group (EMM –3.0 kg, 95% CI –7.3 to 1.3 kg; P<.001). A greater percentage of participants lost at least 5% of their body weight in the intervention (10/11, 90%) versus the control group (2/8, 29%; P=.01). Participants in the intervention group lowered their triglyceride levels (EMM –60.1 mg/dL, 95% CI –91.3 to –28.9 mg/dL) more than participants in the control group (EMM –6.2 mg/dL, 95% CI –46.0 to 33.6 mg/dL; P=.01). Dropout was 8% (1/12) and 46% (6/13) for the intervention and control groups, respectively (P=.07).ConclusionsIndividuals with type 2 diabetes improved their glycemic control and lost more weight after being randomized to a very low-carbohydrate ketogenic diet and lifestyle online program rather than a conventional, low-fat diabetes diet online program. Thus, the online delivery of these very low-carbohydrate ketogenic diet and lifestyle recommendations may allow them to have a wider reach in the successful self-management of type 2 diabetes.Trial RegistrationClinicalTrials.gov NCT01967992; https://clinicaltrials.gov/ct2/show/NCT01967992...

An evidence‐based approach to developing low‐carbohydrate diets for type 2 diabetes management: A systematic review of interventions and methods

“…Of these, 15/29 used high‐frequency contact (defined as ≥2 sessions/month), 10/29 used moderate‐frequency contact (defined as ≥1 session/month), and 4/29 used low‐frequency contact (defined as <1 session/month). Five (5/40) studies reported the use of remote contact (eg, email, phone, web‐based application, online discussion boards) for the majority or all of the scheduled contact, or as a supplement to in‐person contact . One study offered participants a choice between remote and/or in‐person contact …”

“…It appears that no one single CHO amount for T2D is effective, yet there is growing interest in using more pronounced CHO restriction for at least part of the intervention duration. Very‐low‐CHO diet protocols (0‐50 g/d) tended to be described as ketogenic diets and/or set goals to achieve nutritional ketosis as measured by blood ketones . Proposed benefits of nutritional ketosis for T2D include decreased circulating glucose and insulin and increased ketone signalling, which may provide protection against oxidative stress .…”

4. Lifestyle Management:Standards of Medical Care in Diabetes—2018

“…While benefits to low-carbohydrate diets have been described, improvements tend to be in the short term and, over time, these effects are not maintained (74)(75)(76)(77). While some studies have shown modest benefits of very low-carbohydrate or ketogenic diets (less than 50-g carbohydrate per day) (78,79), this approach may only be appropriate for short-term implementation (up to 3-4 months) if desired by the patient, as there is little longterm research citing benefits or harm.…”

A low-carbohydrate survey: Evidence for sustainable metabolic syndrome reversal

“…48,49,50,51,52,53 Studies are also now emerging to show the efficacy, sustainability and other positive effects of lowcarbohydrate diets, especially in those with metabolic disease. 54,55,56,57,58,59,60,61 The definition of a low-carbohydrate diet varies in the literature, but most in the field agree that anything over 130 g -150 g per day is not low carbohydrate. 62 An amount of less than 50 g of carbohydrate per day is considered very low carbohydrate, which would put most adults into nutritional ketosis.…”