Efficacy and safety of a high protein, low carbohydrate diet for weight loss in severely obese adolescents.
21
2010
Efficacy and safety of a high protein, low carbohydrate diet for weight loss in severely obese adolescents. NF Krebs, D Gao, J Gralla. Journal of Pediatrics 2010 August;157(2): 252-258.
US
1
To evaluate the efficacy and safety of a high-protein carb-restricted vs. a low-fat diet on weight loss, metabolic markers, body composition, and cardiac function tests in severely obese adolescents. Study diet was high protein to preserve lean mass.
46
33
11%
32
36 weeks
Y
"Enrolled: 46 Completed: 33 Mean age: ~14 years Body weight: had to be ≥175% of ideal BMI median: ~37 No subject had T2D"
33
Subjects assigned to one of two diets and received instruction on appropriate food choices. Close monitoring for safety every two weeks. After week 13, no clinical contact until follow-up at 24 and 36 weeks. Both groups were informally prescribed an exercise program that included at least 30 minutes of daily moderately vigorous physical activity.
Y
"Targets E: none Carb: ≤20g/d Protein: 2-2.5g/kg ideal weight Fat: none Intake E: 1285 kcal/d Carb: 32g/d, 11%E Protein: 99.5g/d, 32%E Fat: 84g/d, 57%E"
"Target: NS Intake: 11%"
"Target: none Intake: 57%"
"Low-fat E: 70% of need at resting E expenditure Carb: none Protein: none Fat: ≤30%E Intake E: 1465 kcal/d Carb: 188g/d, 51%E Protein: 75.5g/d, 21%E Fat: 49g/d, 29%E"
"Primary: change in BMI-Z-score at 13, 24, and 36 weeks. Secondary: body composition, lipids, insulin resistance, safety of the HPLC diet, and ketosis "
"36 wk BMZ results reported. All other outcomes are for 13 wks. Weight loss and BMI - BG NSS at 36 wks. Total C, LDL-C, and TG - WG SS improvements for both groups, but BG NSS at 13wks; TG was BG SS for HPLC group. HDL-C worsened slightly for both groups. SS only for LC group. Insulin sensitivity improved SS for both groups, but NSS BG. Lean mass lost in HPLC group. No SS effects for safety in either group. "
"Fasting glucose and two-hour glucose WG: N BG: N BG NSS "
0
0
NR
*
*
"WG: N BG: N BG NSS "
0
0
"WG: N BG: N BG NSS"
0
0
"WG: N BG: N BG NSS"
0
0
"WG: N BG: N BG NSS"
0
0
*
*
"BMI-Z and weight WG: Y BG: N Both diets WG SS Weight Baseline→13 weeks HPLC diet 109.3kg→96.1 WG SS LF diet 107.1kg→99.8 WG SS Body composition Fat mass: WG SS for both groups. BG NSS. Lean mass: LF: WG NSS HPLC: marginal WG SS, p=0.05 BG marginal SS, p=0.05 Bone mineral density: WG and BG NSS "
1
0
NR
*
*
NR
*
*
"WG: N BG: N BG NSS"
0
0
"HOMA-IR WG: Y BG: N BG NSS For both groups, the proportion of subjects with score >3.16 was reduced by one third at week 13. Baseline→13 weeks HPLC diet 4.3→2.8 WG SS LF diet 4.9→3.3 WG SS BG NSS"
1
0
NR
*
*
NR
"Safety - Growth (height) did BG NSS - No adverse effects were observed for any of the biochemical indices (complete blood count, serum chemistries, liver function tests, blood urea nitrogen and creatinine) - Only symptom SS higher for one group: headache in HPLC group Reported complaints infrequent, but included low energy, muscle pain, abdominal pain, depression, nausea, dizziness, frequency of urination, dysuria, thirst, bad breath, dry mouth, insomnia, and loss of appetite. "
"The high-protein, low-carb diet is a safe and effective option for medically supervised weight loss in severely obese adolescents."
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