There has been interest in the effect of various types and amounts of dietary carbohydrates and proteins on blood glucose.

Study Number: 48

Year: 2004

Study Design(COUNTRY 1=RCT 2= Systematic Review 3=Non-randomized controlled 4= single arm 5= post hoc analysis 6=Non-systematic review 7. Network meta-analysis 8=other 9 follow up to study): 1

Study background and AIM: "There has been interest in the effect of various types and amounts of dietary carbohydrates and proteins on blood glucose. Aim: to test the hypothesis that a diet that is low in carbohydrate, and particularly low in food-derived glucose, could lower FBG and the postprandial blood glucose in people with T2D."

6 Months or longer: N

Number of subjects and analysis: 8

Low-carb diet arm: "Low biologically available glucose (LoBAG) diet Standardized meals provided Targets E: individualized to maintain weight (2825kcal) Carb: 20%E, 142g/d Protein: 30%E, 210g/d Fat: 50%E, 158g/d Sat fat: 10%E, 30g/d Intake: NR"

Comparison diet ARM(S): "Based on recommendations of the American Heart Association Standardized meals provided Targets E: individualized to maintain weight (2825kcal/d) Carb: 55%E, 388g/d; emphasis on starchy foods Protein: 15%E, 106g/d Fat: 30%E, 94g/d Sat fat: 10%E, 33g/d"

Outcomes Studied: "Primary: blood glucose (HbA1c, FBG) Secondary: lipids, urinary and plasma BOHB, fasting insulin, glucagon, urea, creatinine to test compliance."

Result Summary: "All glycemic control measures SS improved on LoBAG diet, including Hba1c. Only lipid measure with SS change was for TG, favoring the LoBAG diet. Fasting insulin changes were NSS, while net and total 24-h integrated insulin area response were both SS lower on LoBAG diet. Plasma and urinary BHOB were similar on both diets."

FBG, Other Glucose Measures: "FBG, total mean 24hr response WG: Y BG: Y Baseline→5 wk FBG LoBAG diet 167mg/dl→119 WG SS p<0.003 AHA diet 180mg/dl→159 WG NSS Mean 24-hr net glucose area response LoBAG diet 731mghdl→165 WG SS p<0.02 AHA diet 681mghdl→730 WG NSS Total 24-hr net glucose area response LoBAG diet 4746mghdl→3023 WG SS p<0.0004 AHA diet 4998mghdl→4554 WG NSS BG SS P<0.0001 Mean glucose on LoBAG diet 198mg/dL→126 WG SS p<0.0001"

FBG WG Sign: 1

FBG BG Sign: 1

HbA1c: "WG: Y BG: Y Baseline→5 wk LoBAG 9.8%→7.6% (-22%) WG SS p<0.0007 AHA diet WG NSS"

HbA1c WG Sign: 1

HbA1c BG Sign: 1

Total C: "WG: N BG: N WG NSS for both diets BG NSS"

Total C WG Sign: 0

Total C BG: 0

HDL-C: "WG: N BG: N WG NSS for both diets BG NSS"

HDL-C WG Sig: 0

HDL-C BG Sig: 0

LDL-C: "WG: N BG: N WG NSS for both diets BG NSS"

LDL-C WG Sig: 0

LDL-C BG Sig: 0

TG: "Fasting TG & 24-hr total TG area response WG: Y BG: Y Baseline→5 wk LoBAG 246mg/dl→149 WG SS p<0.05 AHA diet WG NSS 24-hr total TG area response Favored LoBAG diet BG SS p<0.05 24-hr integrated net TG BG NSS "

TG WG Sig: 1

TG BG Sig: 1

TG/HDL-C ratio WG Sig: *

TG/HDL-C ratio BG Sig: *

Weight/bmi, Body Composition: mean loss ~4lbs (not intended to be a weight loss intervention)

Weight/BMI WG Sig: *

Weight/BMI BG Sig: *

SBP: NR

SBP WG Sig: *

SBP BG Sig: *

DBP: NR

DBP WG Sig: *

DBP BG Sig: *

Fasting Insulin: "Fasting insulin WG: N BG: N WG NSS for both diets BG NSS Mean AUC response above fasting value and total 24hr AUC response Both SS lower on LoBAG diet (-40%, -25%, respectively) p<0.05. "

Fasting Insulin WG SS: 0

Fasting Insulin BG SS: 0

Insulin Sensitivity/Resistance: NR

Insulin Receptor Improvement WG sig: *

Insulin Receptor Improvement BG sig: *

Inflammation: NR

CRP WG sig: *

CRP BG sig: *

Diabetes Medication Use: NR

Safety Adverse Events: NR

Study Author's Conclusions: "...a LoBAG diet can dramatically reduce the 24-h integrated glucose concentration and consequently the percentage of glycohemoglobin in people with T2D. These positive results occur without a signiﬁcant change in serum lipids, except for a signiﬁcant decrease in tRG concentration."

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

There has been interest in the effect of various types and amounts of dietary carbohydrates and proteins on blood glucose.

Abbreviations:

Number of People in Studies:

Duration of Trial

# of Trials

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