A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes.
"A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes. L Saslow, S Kim, JJ Daubenmier et al. PLoS ONE 9(4) April 2014, 9(4):e91027"
To conduct a trial with good participant retention that compared the effects of two diets on HbA1c and other health-related outcomes in overweight or obese adults with T2D or prediabetes (HbA1c>6%).
"Target: E: none Carb: initially, 20-50g net carb to induce nutritional ketosis Protein: none Fat: none Intake E: 1693.7kcal/d Carb: 57.8 net carbs/d; 14.4%E Protein: 105.7g/d; 24.2%E Fat:110.2g/d; 58%E "
"Medium-carb, low-fat, calorie-restricted, diet (MCCR) consistent with ADA guidelines. Targets: Carb: 45-50%E Protein: same as before study Fat: advised to lower Taught how to count carbs using unit method by registered dietician experienced in teaching about ADA diet. Intake E: 1380.8kcal/d Carbs: 138.5 net carbs/d; 40.7%E Protein: 67.9g/d; 20.5%E Fat: 56.1g/d; 35.1%E "
The LC diet SS improved HbA1c, weight, BMI, waist size, and HDL-C compared to standard diet. Outcomes for other lipids and blood pressure were NSS for both groups.
"HOMA2-IR WG: N BG: N MCCR diet WG NSS. BG NSS "
"C-reactive protein WG: Y BG: N LCK diet 7.3mg/dL→5.8 WG SS, p<0.05 MCCR diet 4.4→3.8 WG SS, p<0.05 BG NSS"
"% who continued use of one or more oral diabetes medications WG: NR BG: Y LCK diet 44% (n = 7) MCCR diet 11% (n = 2) BG SS, p=0.03 "
"No reported clinically evident hypoglycemia Only SS symptoms: Heartburn BG SS reduction for LCK diet Constipation WG increase for LCK diet General aches and pain WG decrease for LCK diet"
One subject dropped out due to moving.
"Both groups reported SS reductions in carb and sugar cravings, emotional eating, hunger, and eating disinhibition, and increased dietary restraint. Differences BG NSS. The LCK group reported SS decreases in diabetes distress, negative mood between meals, and perceived disconnection between psychological and physical states."
"A low-carb diet was more effective than a standard, moderate-carb diet at reducing HbA1c at three months. All subjects in the LCK group showed a decrease in HbA1c. "
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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