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.
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. LR Saslow, AE Mason, S Kim. Journal of Medical Internet Research. 2017 Feb 13;19(2):e36.
To determine whether an online intervention based on researchers' previous findings [(an ad libitum very low-carb ketogenic (VLCK) diet with lifestyle “intervention”] or an online diet program based on the American Diabetes Associations’ “Create Your Plate” diet (ADA diet) would improve glycemic control and other health outcomes among overweight individuals with T2D.
"Enrolled: 25 obese adults with T2D Mean age: ~55 years. 50% male,50% female white - 60% black - 16% Latino - 28% Asian/Pacific Islander - 16% Mean HbA1c: ~7% Diabetes status: ~ 5.5 years. Only included those using only one diabetes medication - metformin. Those enrolled self-rated themselves as conscientious and ready to make dietary changes proposed in the intervention. Completed n=19 (76%)"
"Diet plus instruction on diet; VLCK diet group received intensive behavioral support on a wide range of topics related to eating and wellness; short videos created for the study with printable handouts and links to online resources, such as recipes and recipe books. VLCK diet group used urine ketone strips to check ketone levels during the first few months of the study. "
"ADA's “Create Your Plate” diet (low-fat diet): Emphasizes green vegetables, lean proteins, and somewhat limited starchy and sweet foods. All proportions are based on a 9-inch plate: half the plate is filled with nonstarchy vegetables, one-quarter with carbohydrates, and one-quarter with lean proteins. Reported intake at 32 weeks: E: 1526.4kcal/d Net carbs: 137.2g/d, 36.0%E Protein: 74.4g/d Fat: 57.6g/d Group received minimal behavioral support, but was taught by short videos created for the study, printable handouts and links to online resources, such as online recipes and recipe books. "
Although neither diet was E-restricted, both diet groups reduced kcal intake: at 32 weeks, the VLCK diet group reported a 439kcal/d decrease, and the ADA diet group reported a 217kcal/d decrease, from baseline
"BG SS reported The VLCK diet resulted in SS BG improvement in HbA1c, TG and weight loss. Differences in LDL-C, HDL-C, medication use, psychological measures and dropout rates were NSS BG."
"HbA1c & % lowering HbA1c to <6.5% at 32 wks: WG: NR BG: Y change at 32 wks HbA1c VLCK diet: -0.8% ADA diet: -0.3% BG SS p=0.002 % lowering HbA1c to <6.5% at 32 wks: VLCK diet: 6/11, 55% ADA diet: 0/8, 0% BG SS p=.02 "
"WG: NR BG: N BG NSS "
"WG: NR BG: N BG NSS"
"WG: NR BG: Y change at 32 wks VLCK diet: -60.1mg/dL ADA diet: -6.2mg/dL BG SS p=.01"
"WG: NR BG: Y change at 32 wks VLCK diet: -0.8kg ADA diet: -60.3kg BG SS p=.002"
"Metformin use WG: NR BG: N BG NSS The only diabetes medication used by subjects was metformin. "
"One subject in each group reported experiencing an event that they believed was caused by hypoglycemia (one in the ADA diet group was likely from eating very few calories and the other in the VLCK diet group was after taking a dose of metformin). "
Dropout was 8% (1/12) and 46% (6/13) for the VLCK diet and control groups, respectively (p=.07).
"Psychological measures WG: NR BG: N BG NSS Included diabetes stress, affect, depression, vitality, all of which improved more on the VLCK diet. Some measures worsened on the ADA diet."
Individuals with T2D improved their glycemic control and lost more weight after being randomized to a VLCK diet and lifestyle online program rather than the ADA's conventional, low-fat diabetes diet online program. Thus, the online delivery of the VLCK diet and lifestyle recommendations may allow those with T2D to have a wider reach in the successful self-management of the disease.
AHA - American Heart Association;
ALT - alanine aminotransferase;
AMDR - acceptable macronutrient distribution range;
AST - aspartate aminotransferase;
BG - between study groups;
BHOB - beta-hydroxybutyrate;
DBP - diastolic blood pressure;
E- energy, caloric intake;
eGFR - estimated glomerular filtration rate;
FBG - fasting blood glucose;
GGT - gamma-glutamyl transferase;
HDL-C - high-density lipoprotein cholesterol;
iGFR - isotope glomerurar filtration rate;
LDL-C - low-density lipoprotein cholesterol;
NAFLD - non-alcoholic fatty liver disease;
NR - not reported (or data needed for calculation not available);
N - no;
NA - not applicable;
NS - not specified;
NSS - not statistically significant;
SBP - systolic blood pressure;
SS - statistically significant;
TG - triglyceride;
total C - total cholesterol;
V - varied, mixed;
WG - within a study group;
WMD - weighted mean difference;
Y - yes
Number of People in Studies:
3,296 Enrolled in randomized controlled trials on 25% or less carbohydrates
2,626 Completed randomized controlled trials on 25% or less carbohydrates
79.67% 82% completion of studies
Duration of Trial
1 -2 years
# of Trials
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