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.
23
2017
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.
US
1
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.
25
19
12%
41
32 weeks
Y
19
"Targets Carb: (net carbs) 20-50 g/d Protein: none Fat: none Intake E: 1405.6kcal/d Net carbs: 40.9g/d; 11.6%E Protein: 81.7g/d Fat: 73.1g/d "
"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. "
"Primary: HbA1c Secondary: weight Other: lipids, weight, diabetes-related stress, diet side effects."
"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."
NR
*
*
NR
*
*
"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.
Abbreviations:
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
<6 Months
6-9 Months
1 -2 years
>2 years
# of Trials
36
6
9s
1