A very low carbohydrate, low saturated fat diet for type 2 diabetes management: a randomized trial.
34
2014
A very low carbohydrate, low saturated fat diet for type 2 diabetes management: a randomized trial. J Tay, ND Luscombe-Marsh, CH Thompson et al. Diabetes Care July 28 2014.
Australia
1
"To compare the effects of a very low carbohydrate, high unsaturated/low saturated fat diet (LC) to a high-unrefined carbohydrate, low-fat diet (HC) on glycemic control and CVD risk factors in T2D. "
115
93
14%
57
24 weeks
N
93
"Target: Carb: 14% E, <50g/day Protein: 28%E Fat: 58%E (10% saturated, 48% unsaturated) Intake: E: 1563kcal/d Carb: 56.7 g/day, 14%E Protein: 102.8 g/day, 27%E Fat: 96.5 g/day, 54%E Saturated fat: 10%E"
"High carb (HC) Target: Carb: 53% E, emphasis on low glycemic index foods Protein: 17%E Fat: 30%E (6% saturated, 24% unsaturated) Intake: E: 1587kcal/d Carb: 204.9 g/day, 50%E Protein: 73.6 g/day, 19%E Fat: 44.3 g/day, 25%E Saturated fat: 7.5%E"
"Primary: HbA1c. Secondary: antiglycemic medication changes, lipids, SBP, and DBP and glycemic variability, as assessed by 10 outcome measures, including: area under the curve; min, max and mean glucose, intraday and interday standard deviation, mean amplitude of glycemic excursions (MAGE), continuous overall net glycemic action (CONGA-1 and 4), glucose range, mean of daily blood glucose differences (MODD)."
LC group achieved greater reductions in TG, medications use, and HbA1c, as well as greater increase in HDL-C.
"HOMA2-IR WG: NR BG: N BG NSS HOMA2-%B (beta cell function) WG: NR BG: N BG NSS "
*
0
"C-reactive protein WG: NR BG: N BG NSS "
*
0
"On 3 measures WG: NR BG: Y Assessed using a medication effects score based on potency and dosage of antiglycemic meds and insulin use. Higher MES corresponds to higher antiglycemic medication usage. MES score BG SS p=0.003 Proportion that achieved meds reduction of ≥ 20%: LC diet - 67.4% HC diet - 27.7% BG SS p<0.005 Proportion that achieved meds reduction of ≥ 50%: LC diet - 34.8% HC diet - 17.0% BG SS p= 0.05 "
Similar small proportions experienced symptoms related to exercise program. Two in LC diet group had gastrointestinal complaints.
"LC diet: 79% HC diet: 82% Exercise compliance similar between groups. B-hydroxybutyrate levels increased SS, threefold more on the LC compared with the HC diet after the initial 4 weeks and remained higher throughout the study, indicating adherence to diet. "
"Our results suggest that a very low carbohydrate diet coupled with skills to promote behavior change may improve glycemic control in type 2 diabetes while allowing decreases in diabetes medications."
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