These researchers reported previously that a very low carbohydrate (VLC) diet favorably affected fasting and postprandial TG, LDL subclasses and HDL-C in men but the effects in women were unclear.

Study Number: 16

Year: 2003

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: "These researchers reported previously that a very low carbohydrate (VLC) diet favorably affected fasting and postprandial TG, LDL subclasses and HDL-C in men but the effects in women were unclear. Aim: To compare the effects of a VLC and a lowfat (LF) diet on fasting lipids, postprandial lipemia [excess fats in the blood] and markers of inﬂammation in women. "

6 Months or longer: N

Number of subjects and analysis: 10

Low-carb diet arm: "VLC diet Targets E: individualized and based on resting E expenditure. Carb: ~10%E Protein: ~30%E Fat: ~60%E Intake: E: 7.5MJ/d (~1791kcal/d) Carb: 43g/d, 10%E Protein: 128g/d, 29%E Fat: 118g/d, 60%E"

Comparison diet ARM(S): "LF diet E: individualized and based on resting E expenditure. Carb: ~55%E Protein: ~20%E Fat: ~25%E Intake: E: 7.5MJ/d (~1576kcal/d) Carb: 249g/d, 62%E Protein: 68g/d, 17%E Fat: 34g/d, 19%E"

Outcomes Studied: Primary: blood lipids, including LDL subclasses and postprandial TG, markers for inflammation.

Result Summary: "Neither diet SS affected markers for inflammation or most LDL-C subclasses. Overall, the VLC diet resulted in greater reduction in CVD risk, compared to the LF diet, due to SS improvements in fasting and postprandial TG, HDL-C the total C:HDL-C ratio, and the SS decrease in very low density lipoproteins. The LF diet compared to the VLC diet resulted in SS decreases in total C and LDL-C."

FBG, Other Glucose Measures: NR

FBG WG Sign: *

FBG BG Sign: *

HbA1c: NR

HbA1c WG Sign: *

HbA1c BG Sign: *

Total C: "Total C WG: N BG: N Total C: HDL ratio WG: Y BG: N VLC diet group SS worsened total C from baseline due to increases in LDL-C and HDL-C. Total C Baseline→4 wks VLC diet 4.61mmol/L→5.3 WG p≤0.05 LF diet 4.78mmol/L→4.53 WG NSS BG SS p≤0.05"

Total C WG Sign: 0

Total C BG: 0

HDL-C: "WG: Y BG: Y Baseline→4 wks VLC diet 1.28mmol/L→1.69 WG p≤0.05 LF diet 1.30mmol/L→1.20 WG NSS BG SS p≤0.05"

HDL-C WG Sig: 1

HDL-C BG Sig: 1

LDL-C: "Total LDL-C WG: N BG: N LDL subclasses, in general WG: N BG: N VLDL WG: Y BG: Y LDL-C:HDL-C WG: N BG: N Total LDL-C Baseline→4 wks VLC diet 1.28mmol/L→1.69 WG p≤0.05 LF diet 1.30mmol/L→1.20 WG NSS BG SS p≤0.05 LDL subclasses: NSS changes in % or concentration of LDL subclasses with either diet The VLC diet resulted in SS % decrease in very LDL and one type of intermediate-density LDL. "

LDL-C WG Sig: 0

LDL-C BG Sig: 0

TG: "Total TG WG: Y BG: Y Oral fat tolerance test WG: Y BG: N TG generally peaked ~2hrs after the meal and gradually returned to baseline 7-8 hrs later. Only the VLC diet resulted in a SS WG decrease, comparing results at baseline to 4 wks. Total TG Baseline→4 wks VLC diet 0.86mmol/L→0.60 WG p≤0.05 LF diet 0.79mmol/L→0.82 WG NSS BG SS p≤0.05"

TG WG Sig: 1

TG BG Sig: 1

TG/HDL-C ratio WG Sig: *

TG/HDL-C ratio BG Sig: *

Weight/bmi, Body Composition: NR

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: NR

Fasting Insulin WG SS: *

Fasting Insulin BG SS: *

Insulin Sensitivity/Resistance: NR

Insulin Receptor Improvement WG sig: *

Insulin Receptor Improvement BG sig: *

Inflammation: "CRP and pro-inflammatory cytokines (IL-6 and TNF-a) WG: N BG: N"

CRP WG sig: 0

CRP BG sig: 0

Diabetes Medication Use: NR

Safety Adverse Events: NR

Retention and Compliance: "100% Excellent compliance"

Other: "Male-female differences found in this study vs similar one on normal-weight men (6-wk on VLC diet): Men/Women total C: +5%/16% LDL-C: +4%/15% HDL-C: +12%/33% postprandial TG: -29%/31%"

Study Author's Conclusions: "While results are ""not to be used to make recommendations to the public,"" ... a short-term isoenergetic VLC diet SS decreased fasting and postprandial TG, SS increasedHDL-C, SS decreased the total C:HDL-C ratio and did not affect markers of inﬂammation. Our results indicate that in the short term, there is not an adverse response in terms of accepted biomarkers of CVD risk in healthy normolipidemic women, even in the absence of large reductions in body mass."" "

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

These researchers reported previously that a very low carbohydrate (VLC) diet favorably affected fasting and postprandial TG, LDL subclasses and HDL-C in men but the effects in women were unclear.

Abbreviations:

Number of People in Studies:

Duration of Trial

# of Trials

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