Randomized clinical trial of standard dietary treatment versus a low-carbohydrate/ high-protein diet or the LighterLife Programme in the management of obesity. C Rolland, M Hession, S Murray et al. Journal of Diabetes.
44
2009
"Randomized clinical trial of standard dietary treatment versus a low-carbohydrate/ high-protein diet or the LighterLife Programme in the management of obesity. C Rolland, M Hession, S Murray et al. Journal of Diabetes. 2009 Sep;1(3):207-17. Epub 2009 Jun 26. "
UK
1
"To assess changes in weight, body composition and CVD risk in response to a very low-carbohydrate, high- protein diet (VLC+HP) or a moderately low-carb, E-restricted (Mod Carb) diet with commercial foods provided. "
72
62
20%
40
9 mos
Y
"72 obese adults who had not lost >10% weight loss after 3 mos on low-fat, reduced-E diet Mean BMI: 42-46 Completed n=62 (86.1%)"
62
"120 obese subjects underwent lowfat, E-resticted diet. Those not achieving diet goal were randomized to a VLC+HP diet or the moderate-carb diet + commerical foods (Mod Carb). The VLC+HP diet group received support via phone and email, recipe and educational booklet. No other support. The Mod Carb diet received commercial shakes, soups and snacks; weekly group meetings on diet, exercise, motivation; phone and email support. The diet was in 2 phases: 3-mo weight loss and 6-mos maintenance (optional) in which regular food was reintroduced."
Y
"VLC+HP diet Targets E: 800-1500kcal/d Carb: 20%E, ≤40g/d Protein: 40%E Fat: 40%E Intake: NR"
"Target: 20% Intake: NR"
"Target: 40% Intake: NR"
"Moderate Carb diet/LL diet (Mod diet) Targets E: 550kcal/d Carb: 36%E Protein: 36%E Fat: 28%E Intake: NR"
Both diets met definition of a low or moderate carb diet.
Primary: weight, body composition, CVD risk factors
"Some WG levels NR. For reporting here, the VLC+HP diet is regarded as the low-carb diet, although both tests were within range by definition of low/moderate carb intake. Greater WG (and some SS BG) improvement was seen with the Moderate Carb diet, which offered significantly greater behavioral support to subjects."
"WG: N BG: N Baseline→9mo VLC+HP WG NSS Mod Carb 5.2→4.9 WG SS p NR BG SS p=0.010 "
0
0
"WG: N BG: N Baseline→9mo VLC+HP WG NSS Mod Carb 5.6%→5.4 WG SS p NR BG SS p=0.012"
0
0
"WG: N BG: N Baseline→9mo VLC+HP WG NSS Mod Carb 4.0mmol/L→3.6 WG SS p NR"
0
0
"WG: N BG: N BG NSS Baseline*→9mo VLC+HP WG NSS Mod Carb 1.31mmol/L→1.38 WG SS p NR BG NSS *2 groups SS different at baseline"
0
0
"WG: N BG: N BG NSS Baseline→9mo VLC+HP WG NSS Mod Carb 3.1mmol/L→2.9 WG SS p NR BG NSS"
0
0
"WG: N BG: N Baseline→9mo VLC+HP WG NSS Mod Carb 1.3mmol/L→1.1 WG SS p NR BG SS p=0.049"
0
0
*
*
"Weight and BMI WG: Y BG: N Both diets resulted in SS WG improvement for weight, BMI, % body fat, fat mass, and waist size. Mod Carb diet also resulted in SS WG improvement in free-fat mass*. Mod Carb diet was SS favored BG for all measures but fat-free mass. Weight Baseline*→9mo VLC+HP 111.6kg→109.6 Mod Carb 122.6kg→107.5 WG SS p NR BG SS p=0.007 *2 groups SS different at baseline"
1
0
"WG: N BG: N BG NSS Baseline→9mo VLC+HP WG NSS Mod Carb 134.8mmHg→128.2 WG SS p NR BG NSS "
0
0
"WG: N BG: N BG NSS Baseline→9mo VLC+HP WG NSS Mod Carb 87.7mmHg→83.2 WG SS p NR BG NSS "
0
0
NR
*
*
NR
*
*
NR
*
*
NA
"Renal and hepatic markers Neither diet group had adverse levels, but some WG and BG outcomes were SS: Urea - LC+HP diet: WG SS increase - Mod Carb diet: WG SS decrease BG SS p=0.03 Creatinine - LC+HP diet: WG NSS - Mod Carb diet: WG SS decrease BG NSS eGFR - LC+HP protein diet: WG NSS - Mod Carb diet: WG SS increase BG SS p=0.035 Alanine aminotransferase c-Glutamyl transferase - LC+HP diet: WG NSS - Mod Carb diet: Both WG SS decreases BG SS p=0.016, 0.008 "
"Greater weight loss and improved CV risk were achieved with the LL [Moderate Carb diet], which mostly reflects the patient support provided for each dietary treatment."
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