SBU: Schematisk sammanfattning av korttidstudierna

Schematisk sammanfattning av studierna

 

Author

Study design
Setting
Duration

Population/Patient
characteristics at baseline

Intervention/referencegroup

 

Method of dietary measurement

Results
HC: highcarb period
LC: lowcarb period

Comments

Coulston[6]

1987

USA

 

Randomized, cross-over
Medical department, Stanford Univ
2 x 15 days

In-patients with type 2 diabetes; 5 received oral antidiab.drugs
Gender: 2w/7men
Age               63±2
BMI              26.3±1.1
Glucose        10.8±1.1              

                            

40:20:40(SFA 17,4)/
60:20:20 (SFA 8.7)
n = 9
Calories necessary to maintain bw. PUFA/SFA equal. Each ingredient of thefood was similar except for the amounts
No drop-outs

All food was provided by the researchcenter’s kitchen. Detailed description of the diet in the paper.

Glucose and insulin: ns
Glucose and insulin area:
LCsmaller***
Urinary glucose
:
HC twice**
TG:
LC lower***
VLDL
:LC lower*
tC
: ns
HDL:
LC higher*
LDL
: ns
No significant differences between treated and untreated patients

High quality
In spite of the small number of participants there was a significantworsening of both glycaemia, glucosuria; HDL and TG after the HC period

 

Author

Study design
Setting
Duration

Population/Patient
characteristics at baseline

Intervention/referencegroup

Method of dietary measurement

Results
HC: highcarb period
LC: lowcarb period

Comments

Coulston [7]
1989
USA

 

Randomized, cross-over
Medical department, Stanford Univ
2 x 15 days

In-patients with type 2 diabetes; 6 received oral antidiab.drugs
Gender: 3 w/5 men
Age               66±3
BMI              25.5±0.8
Glucose        10.5±1.1
TG                 2.18±0.27

                 

                  

0:20:40 (SFA 20)/
60:20:20 (SFA 9)
n = 8
See Coulston 1987
No drop-outs

All food was provided by the researchcenter’s kitchen. Detailed description of the diet in the paper.

Glucose and insulin: ns s
Glucose and insulin area
: HC larger***
Urinary glucose
:HC twice*
TG
: HC higher***
VLDL
: HC higher*
tC
: ns
LDL
: LC higher* 
HDL
: LC higher***
VLDL
: HC higher*
tC/HDL-C
: ns

High quality
In spite of the small number of participants there was a significantworsening of both glycaemia and lipids after the HC period except that asmall, but significant rise of LDL was seen in the LC period

  

Firstauthor

 

Studydesign

Setting

Durationof follow-up

Population/Patient

characteristicsat baseline

(lowcarb lowfat)

 

Intervention/referencegroup

 

Method of dietary measurement

Results
LC period compared with HC period
% change

Comments

Fuh[8]
1990
USA and China

 

Cross-over

ChineseMed Dept

2x15days

Type 2 diabetics with hypertension. All received oral antidiabeticdrugs

Age  58 (49-64)

BMI: 25.8 (21-32)

Glucose: 9.3 (7.3-11.3)

BP: 126/82 (114/76-136/88)

Gender    0 w/11 m

 

40:20:40(SFA 17)
60:20:20 (SFA 8.5)
More soybean milk and oil, beef and “pudding” in the LCHF group, morerice, bean curd, pancake and sweet milk in the HCLF group. In both groupscalories necessary to maintain bw
n=11
No drop-outs

Food was prepared at the medical center.

Insulin, glucose:ns
Insulin*** and glucose*** areas
: larger in the HC group.
TG
lowest after the LC period.***
TC, HDL and LDL:
ns

High quality
TG and glycaemia worsened significantly on the highcarb-lowfat diet

  

 

First author

 

Studydesign

Setting

Durationof follow-up

Population/Patient
characteristics at baseline

 

Intervention/referencegroup

  

ethod of dietary measurement

Resultsat week 14
Highmono/highcarb
% change

 

Study quality and relevance
Comments

Garg [9]
1994
USA

 

Randomizedcross-over study
Four university medical departments.

2x 6 weeks with 1 week wash-out

Halfof the participants in each group continued with the diets for 8 weeks

Type 2 diabetics, all treated with glipizide
Gender: 9 w/33 men
Age        58(35-78)
BMI       28.1(23-33)
BW        82kg
Glucose 5.6-11.1
TG         0.61-4.97

                            

Highcarb55:15:30 (mono 10)
Highmono: 40:15:45 (mono 25). SFA 10 % in both groups
Calories necessary to maintain bw . Food similar in each group. For adifferent energy level all food items were proportionately reduced orincreased.
n = 42. 
20 started with the highmono diet, 22 started with the HC diet.
No drop-outs

All meals were prepared in metabolic kitchens.At least one meal per day was eaten at the institution. The food for therest of the day  was suppliedin packaes to be consumed at home.

BW: 0/0
tC
: +1.6/+5.3***
LDL
: +2.8/+5.6*
HDL
: +1/+2.2*
TG
: -4.7*/+1.3
Glucose –10*/+12****
Insulin –10*/+9**
Glucose*** and insulin* area
measured on day 42significantly lower on the highmono diet

High quality
Highmono-lowcarb significantly better than highcarb-lowfat as regardslipids and glycemia independent on bw

 

 

Firstauthor

 

Study design
Setting
Duration of follow-up

Population/Patient
characteristics at baseline
Women/men
Age (mean, range) 

ntervention/referencegroup

  

Method of dietary measurement

Results
% change
(after 25% carb/after 55% carb)

Studyquality and relevance
Comments

Gutierrez[10]
1998
USA

 

Cross-over
Sansum Medical Research Foundation
8+12 weeks

Type 2 diabetes
20women 8 men
Previously treated with sulfonylureas
(n =19)
Age     67 ±6
BW      76 ±15
BMI 27.9±4.8
Syst.BT 136±11
Diast. BT 83±6
HbA1c 9.9±1.9
Glucose 258±51
Diab.duration (y) 8±8
Not treated previously
Age     65 ±7
BW      82±20
Syst.BT 129±16
Diast. BT 81±6
HbA1c 9.2±1.6
Glucose 262±71
Diab.duration (y) 4±4

Subjectswere taught once weekly to exchange to a diet of 25:45:30. After 8 weeks switched to an ADA diet of 55:20:25 for 12 weeks.
Calories necessary to maintain bw. During the highprotein period allstarch amd milk portions were substituted by protein portions; only onefruit protion per day
N= 28
No drop-outs

All ingested food was recorded during thewhole trial and analysed once a week by nutritionists

Previouslytreated with sulfonylureas
BW
:-1.4***/+2.4
BMI
:-5/+17
Syst BT
:-5/+2
Diast BT
:-4*/-1
HbA1c
:-18**/+9,9**
Glucose
: -26***/-5.1
Not treated previously
BW
: -9.8/1.4
BMI
: -1/+5.8
Syst BT
: +4/-4
Diast BT
: -2.6/-0.9
HbA1c
: -15.2*/+15.2
Glucose
:-34 **/+35*

 

 

 

Highquality
Improved glycemia on the lowcarb diet in spite of discontinuation ofsulfonylureas. Deterioration of glycemia on the highcarb diet 

 

 

Single-arm(Ej medtagit i diagrammen)

First author

 

Study design
Setting
Duration of follow-up

Population/Patient
characteristics at baseline

Interventions/reference group
Number at baseline
Drop-out rate

Method of dietary measurement

Results
% change

 

Comments

Vernon [13]
2003
USA

 

Single-arm; retrospective
Private practice and university hospital
8 months (2-30 months)

Diabetics;13 type 2, one type 1
Gender: 8w/6 men
49 (35-52)
BW        123±31
tC          5.74±1.32
HDL-C    1.15±0.27  
LDL-C  3.38±0.64
TG        317±164
HbA1C    10±2.2
tC/HDL    5.2±1.5
TG/HDL   8.0±5.5

N = 14
Selected because they were compliant; number of drop-outs not given
<20 g carb with slow increase until ketonuria disappeared
Unlimited animal food, 1-2 cups salad or lowcarb vegetables

 

 

Instructions once a week

BW               -9.7      
tC
                  -14       
DL-C
         +8    
LDL-C          -9         
TG                 -50**
HbA1C      -41***
tC/HDL     -21*    
TG/HDL    -55*  
In the paper results are also given for eachparticipant

High quality
Significant improvements were achieved in spite of the low number, and inspite of discontinuation of oral hypoglycaemic agents and a lowering ofthe insulin dose

 

Single-arm(Ej medtagit i diagrammen)

First author
Year
Country

Study design
Setting
Duration

Population/Patients
±SD

Interventions/reference group
Number at baseline

Method of dietary measurement

Results
% change

Comments

Yancy [14]
2003
USA

 

Single-arm
Outpatients in research center
16 weeks

Overweight,type 2 diabetes
Gender = 0 w/7 men
Age        54.7(35-75)
MI              42.5±5.8
BW               129±22.3
BP 144±16/ 88±10
Glucose        10.1±2.9
tC                  4.28±1.36
HDL-C          1.04±0.17
LDL-C           2.13±0.59
TG                 291±410
HbA1C               7.4±1.2

<20 g carb
Unlimited amounts of meats, poultry, fish, shellfish, eggs; 2 cups ofsalad vegetables, 1 cup of lowcarb vegetables, 4 ounces of cheese, limitedamounts of cream, avocade, olives and lemon juice. Slowly increase ofcarbs until ketonuria disappeared
No drop-outs

Dietary instructions every other week

BMI              -10***
BW
              -10***
BT, syst       
-9
       diast        -15*
Glucose
       -31
tC
                  -8
HDL-C
           0 
LDL-C
          +11
TG
                 -62
HbA1C
         -20*        

High quality
In spite of  a reduction ofthe antidiabetic pharmaceuticals and in spite of the low number ofparticipants, several measures of the metabolic syndrome were loweredsignificantly

 

 

Firstauthor

 

Study design
Setting
Duration of follow-up

Population/Patient

characteristicsat baseline

Lowcarb/highcarb

Lowcarb/highcarb 
Diet
Number at baseline 

Method of dietary measurement

Results
Lowcarb/highcarb
% change

Comments

Gannon[15]
2004
USA

 

Randomized, cross-over study
University departments
2 x 5 weeks with a 5 weeks washout period

Untreated, mild type 2 diabetes

0 w/8 men with stable bw

Age 63 (51-82)

BMI 31 (27-36)

BW  98±4.5/99±4.5

Glucose 9.3±0.7/10±0.6

Insulin 12±2/12±2

tC  4.82±0.26/5±0.18

HDL 0.95±0.05/0.97±0.04

LDL 2.69±0.18/2.69±0.23

TG 2.77±0.3/2-97±0.4

HbA1C  9.8±0.5/9.8±0.5

Isocal
20:30:50(11 SFA)/
55:15:30(9.5 SFA)
(carb:prot:fat)
Based on a 3-day food frequency questionnaire Calories necessary tomaintain bw weight
n = 8
no drop-outs

All food was prepared by the institution andpicked up by the participants every 2-3 day

 

BW: -2/-1
Glucose:

-25**/-12
Glucose area:
Largest after lowfat***
Insulin area:
Largest after lowfat**
HbA1C: -22***/0
TG:
-39*/-14
HDL: -2.7/-2.6
LDL: +4.8/0
tC:
-5.8/-5.8       

High quality
In spite of the low number of participants the highprotein/lowcarb dietlowered glucose, glucose and insulin area, HbA1C and TG significantlywithout significant changes of HDL, LDL or tC.

 

 

First author

 

Study design
Setting
Duration of follow-up

Population/Patient
characteristics at baseline

Interventions/reference group
Number at baseline 

Method of dietary measurement

Results

 

Comments

Miyashita [16]
2004
Japan

 

RCT
Inpatients at a university hospital
4 weeks

Obesesubjects with untreated type 2 diabetes
Gender 6 w/16 men
Age: 52.4 (+ 13)
BMI  27±4/27±2
BW       73/71
Glucose 11.1±2/11.5±3
tC  4.95±0.9/4.94±1.2
HDL  0.97±0.3/1-0±0.4
TG  1.97±2.3/1.95±1.5
HbA1C  10.2±/9.8±

39:25:35(SFA10.3)/ 62:26:10 (SFA 3)
(carb:protein:fat)
Both arms lowcaloric
(1000kcal)
n: 11/11
No drop-outs

Diet prepared by the hospital

All participants were hospitalised during thetest period

BW: -9/-7
HDL:
+16**/0   
tC:
-20/-20
TG:
-51/-47
Glucose: -50/-50
Insulin: -39*/-9

                            

High quality
In spite of the low number and the short period the moderate lowcarb dietimproved insulin and HDL significantly. However, the results were mostlikely strengthened by the pronounced weight loss in both groups.

 

  

 

First author

 

Study design
Setting
Duration of follow-up

Population/Patient
characteristics at baseline 

Intervention/reference group

  

Method of dietary measurement

Results

 %change between day 8 and day 22

 

Comments

Boden [17]
2005
USA

 

Cross-over
General clinical research center of a University hospital
1+2 weeks

Obesepatients with type 2 diabetes
In-hospital study
Gender 7 w/3 m
Age: 51 (36-54)
BMI       40.3±5.7
BW        114,8±13

 

 

Week1 (usual diet)
39.7:15.7:44.6 (SFA 15)
Week 2-3:
3.9:28.1:68 (SFA 23)
N =10
No drop-outs

All food were weighed and recorded at thehospital (served minus returned items)
No caloric restriction

BW:  -1.8*

Glucose: -16*

TG: -35%***

HbA1C: -6.8**

tC: -9.4*

LDL-C: -2 ns

HDL-C:-1.7 ns  

Insulin*and glucose** areas were significantly smaller during  thelowcarb period

High quality
In spite of the low number of participants, an increased intake of SFA andan unlimited caloric intake, the ketogenic diet resulted in improvementsof almost all parameters measured, including body weight. Five of sevenpatients reduced or stopped their antidiab. medication

 

First author

 

Study design
Setting
Duration of follow-up

Population/Patient
characteristics at baseline

Intervention/reference group 
Number at baseline

Method of dietary measurement

Results
HC/HP/HF
% change, intention to treat analysis.
Significance shown for diff between HC and HF only

Comments

McAuley [18] 2005
New Zealand

 

RCT
Out-patients at university departments
24 weeks

Insulin-resistentobese women
Gender 93 w/0 men
BMI 36.6:34,5:36
BW  98:93:96     
BT :126/81:124/80:130/83  
Glucose  5:5.1:5.1
TC  5.9:5.7:5.8
HDL-C  1.16:1.21:1.17
LDL-C  3.9:3.7:3.8
TG  1.77:1.86:1.78
Age 30-70

All3 groups: No caloric restriction
Highcarb, high fiber diet based on the guidelines from the European Assoc for the study ofDiabetes: 45:21:28 (SFA 10). N=32; 2 drop-outs (too busy; problems withveins)
High-protein diet (Zone diet
):
35:26:35(SFA 11).N=30; 3 drop-outs (diet too restrictive)
High-fat diet (Atkins)
26:24:47(SFA 19) with <20 g carb initially increasing until ketonuriadisappeared. N=31; 4 drop-outs (2 too busy,1 diet too rich, 1 no perceivedbenefit)

Weekly instructions and dietary records duringthe first 16 weeks.

BW-4.8/-7.4/-7.4
TG
–18/-31/-40***
TC 
-10/-8.8/-5
LDL
–10/-8/-5
HDL
–3.4/+1/+7.7*
Glucose
-6/-3.9/-5.9
Insulin
–28/-24/-39
Syst BT –1,6/-2.4/-3
Diast
+1,2/-1,3/-2,4

 

High quality
The highcarb group had worse results on most parameters.

First author

 

Study design
Setting
Duration of follow-up

Population/Patient
characteristics at baseline

Intervention/reference group 

 

Method of dietary measurement

Results
Percent changes

Comments

 

Yancy [19]
2005
USA  

 

Single-arm
University hospital outpatient clinic
16 weeks

Obesetype 2 diabetics
Gender 1/20
Age        56 ±7.9
BMI        42±5.8
BW         131± 18.3
Syst BT    135±14.8
Diast          79±14,9 Glucose  9.08±4,09
tC             4.61±1,4
HDL-C     0.92±0,2
LDL-C    2.51±0,64
TG          2.69±2,87
HbA1C      7.5±1,4

<20 g carb at baseline
58:15:27 at the start
10:31:59 at week 16
Increase of carb intake until ketonuria disappeared. Unlimited animal food,1-2 cups salad or lowcarb vegetables
N: 28 at baseline
7 drop-outs (unable to adhere to study meetings and unable to adhere tothe diet)

Food records (4 consecutive days incl aweekend) collected at baseline and at week 2, 8 and 16

BW        ‑6.6***
Syst BT
  +0,2     ns
Diast        
-6.4 ns
Glucose
-16.6*
tC
           -1.5  ns
HDL-C
  +7.6  ns
LDL-C
  +10.4 ns TG        -41,6*** HbA1c  -16*** Diabetic medicine was lowered in 9 patients and discontinued  in 8.                            

High quality
Highly significant improvement of glycemia. Insignificant elevations ofHDL and LDL; significant lowering of TG

 

                         

  

First author

 

Study design
Setting
Duration of follow-up

Population/Patient
characteristics at baseline
(LC/LF)

Intervention/referencegroup
Number at baseline

 

Method of dietary measurement

Results
% change
LC/LF

Comments

Daly [20]
2006
UK

 

RCT
Outpatient clinics at three British hospitals
3 months

Obese, poorly controlled type 2 diabetes
Gender 53 w/49 m
Age    58.2±1.6/591±1.5
BMI   35.4±0.7/36.7±1.3
BW  101.6±1.8/102.3±2.5
BT, syst   146±2.5/139±2.3   
       diast  80±1.4/79±1.5  
Glucose  11.9±0.7/11.4±0.6
tC 4.85±0.1/4.94±0.2
HDL 1.2±0.04/1.21±0.06
TG  2.48±0.2/2.57±0.3
HbA1C  9±0.2/9.1±0.2

Lowcarb/lowfat
33.5:26.4:40.1(SFA 13.9)/
45.2:20.9:32.9(SFA 11)
Both groups calori-restricted
1290/1434 kcal
n = 51/51
Drop-outs 11/12. 1 was diagnosed with cancer prior to intervention, onedied in a car accident. No causes given for the rest.

 

5-day diary at week 11, verified at the end
37 diaries were analysed in each group

BW: –3,5/-0.9***
tC/HDL-C
    
-11,9/-2,4*
TG
-27/-9,7 ns
Sys. BP
 -4,3/-0,3 ns
HbA1c
–6,1/-2,5 ns
Insulin dose was lowered in 85 % of the patients in the LC group, but onlyin 21 % in the LF group

Medium quality
Significantly better outcome in the lowcarb group as regards bodyweightand lipids, but not significant for glycaemic control, probably becausethe diff between carb intakes was too small.

 

 

First author

 

Studydesign
Setting
Duration of follow-up

Population/Patient

characteristicsat baseline

(lowcarb/lowfat) 

Intervention/referencegroup
Number at baseline
Drop-out rate

Method of dietary measurement

Results
Percent change

Comments

Dyson [21]
2007
UK

RCT

ResearchUnit , Oxford Centre for Diabetes, Endocrinology and Metabolism

3months

Type 2 diabetics

Age       54±9 (mean of both groups)

Gender  9 w, 4 m

BMI      36.5/33.3

BW       99.7/96.9

tC         4.8/4.7

HDL      1.24/1.47

LDL       2.70/2.69

TG       1.8/1.2

HbA1C 7.2/7.5

39.3:19.8:34.4/
17.3:31.1:46.2
Both groups were advised to avoid too much satfat and daily 4-5 portionsof fruit and veg and to lower cal intake by 500 kcal/d. The lowfat groupinstructed to eat lowglycaemic index carbs. Total energy intake restrictedin both groups
n =13
One drop-out in the lowfat group (dissatisfied by being placed in thatgroup)

Individual advise given by dietitians +written information.
Dietary intake measured by validated 3-day food diary at baseline and ateach month interval

BW:-8**/-0.8
tC:
    0/-2.1
HDL:
 +6.4/-8.8
LDL: 
+8.9/+2.2
TG:   
-33/+8.3
HbA1c: 
-5.6/-2.7

High quality
LC-group had etter outcome for all parameters, but not statisticallysignificant

 

 

First author

 

Studydesign

Setting

Durationof follow-up

Population/Patient
characteristics at baseline 

Intervention/referencegroup

 

Method of dietary measurement

Results
Percent change

Comments

Nuttall [22]
2007
USA

Cross-over

Universitydepts. of medicine and Food Science

5weeks

Mild, untreated type 2 diabetes
Age     59 (50-67)
Gender     0 w, 8men
BW      94±5.1
tC        4.9±0.4
LDL:     2.9±0.4
HDL     1.0±0.1
TG        2.1±0.3   
Glucose: 12.6±1
Insulin: 8.4±1.1
HbA1C  10.8±0.4

29:33:40(SFA 11)/
55:15:20 (SFA 10)
Calories necessary to maintain bw
n = 6
no drop-outs

All food was provided from the centre kitchen.Participants returned every 2-3 day to pick up food and for interviewabout diet compliance.

BW:-1.1
Glucose:
-40***
Glucose area +***
Insulin:
+7.1 ns
Insulin area:
0
HbA1c::
-13****
TG:
-41%**
tC:
-19.6**
LDL: -15.9 ns
HDL: -8.1 ns

 

High quality
The starting values were not given for the high-carb arm; these results“were similar as reported previously” (Gannon et al 2004)
In spite of the low number of participants significant improvemens of fastglucose, glucosea area, HbA1c, TG and tC

  

First author

 

Study design
Setting
Duration

Population/Patient
characteristics at baseline 

Intervention/referencegroup

 

Method of dietary measurement

Results
LC/HC
% changes

Comments

Westman [23]
2008
USA

 

RCT
Outpatients, Dept of Medicine, Duke University
24 weeks

Obesetype 2 diabetics
Completers:
Lowcarb:
Age        51.2±6
Gender 14 w/7 men
BMI       37.8±6.7
BW        108.4±20.5
Highcarb:
Age      50±8.4
Gender: 23w /6 men
BMI:     37.9±6BW:    BW:      105.2±19.8          

Lowcarb-ketogenicdiet:
13:28:59 (n=38).No caloric restrictions. Free intake of animal and dairyfood.
Highcarb-lowglyc.index:

44:20:36 (n=46)
Reduced caloric intake
Drop-outs: 17 in each group.
Refused assigned diet 3/1
Unsatisfied with the diet: 2/1
Lost to follow-up: 2/2
Too busy: 2/3
Relocated: 1/1
No reason: 7/9
Difficulties adhering: 0/1

Food records of 5 consecutive days completedat baseline and weeks 4,12 and 24

BW         -10.6*/-6.6*
Insulin
   -29.4*/-14.9*
Glucose
  -11.1*/-9.6
HbA1c
   -17*/-0.7
HDL
        +12.7*/0
LDL
        +0.1/-2.5
TG
         -32*/-11.5
Syst. BP
-11.5*/-7.6*
Diast
     -9.7*/-6.6*
tC         -2.3/-3

 

Medium-high quality
Significantly larger loss of BW and BMI in the lowfat group in spite oftheir free access to calories and animal food. No adverse lipid effects.Better glycemic effects in the lowcarb group and larger weight lossalthough only patients in the highcarb group were instructed to reduce thecaloric intake.

 

First author

 

Studydesign

Setting

Duration

Population/Patient
characteristics at baseline
(lowcarb/lowfat)

Intervention/referencegroup

 

Method of dietary measurement

Results
% changes
(Intention-to-treat)

Comments

Davis [24]
2009
USA

 

RCT

Outpatients,

ClinicalEesearch Center, Albert Einstein Coll. of Medicine

Obese type 2 diabetics
Age        54±6/53±7
Gender   45w/9m 37w/13m
BMI       35±6/37±6
BW        93±18/101±19
BT, syst   125±18/130±17
       diast  73±9/77±10
tC          4.4±0.8/4.3/0.9
HDL       1.3±0.2/1.2/±0.3
TG                 1.4/1.4
HbA1C  7.5±1.5/7.4±1.4
Medication (%):
Metformin:         78/86
Sulfonylurea:     44/52
Insulin:               35/24Chol.lowering:   62/56

Lowcarb: 33:23:44 (SFA 13). Atkins type. Initially 25 g carb with slowincrease
Lowfat
: 50:19:31 (SFA 9)
Calories necessary to maintain bw
N: 55/50
Attrition:  3 months: 91 %
                6 months: 80 %
                12 months: 81 % No difference between the two arms                    

 

During the trial six 30 min individualscheduled instructions  with adietician. Single-day 24h recall by interviews at baselinge, 6 months and12 months. Daily food diaries were also reviewed during the study visits

BW   -3.3/-3.1
tC
     +2.3/-3
HDL
+12.3/+5**
LDL
 -1.6/-7.5
TG
    -10.7/-0.71
Syst. BP
+1.6/-1.4
Diast
      -4/-2.9
HbA1c
 -0,27/+3.2
Change of medicine dosage (units):
Insulin (units)
            -10±14/+4±19
Sulfonylurea  (mg)
            -1.6±3.6/-1.6±3.6

Highquality
Most results in favour of lowcarb, but most differences werenonsignificant; possibly because it was an intention-to-treat analysiswith 14 drop-outs

  

Firstauthor

 

Studydesign

Setting

Durationof follow-up

Population/Patient

characteristicsat baselinelowcarb/lowfat

 

Intervention/referencegroup
Number at baseline
Drop-out rate

Methodof dietary measurement

Results
Lowcarb/lowfat
*signif.between groups

Comments

Volek[25]
2009
USA

 

RCT

Departmof Nutritional Science, Univ of Connecticut

12weeks

Healthy people with metabolic syndrome

Age         33±11/37±13

Gender    20 w + 20men

BMI         33.5±5/32.1±4

BW         97±14/94±15

TC       5.33±0.7/5.23±0.8

HDL       0.92±0.2/1.0±0.2

TG       2.38±0.7/2.11±0.7

HOMA 2.9±2.5/1.7±1.1

12:28:59 (SFA 29)/
56:20:24 (SFA 6)
n 20/20
No caloric restrictions
no drop-outs

Weekly,personal, individual dietary counceling. Detailed dietary booklets. 7-dayfood records week 1, 6 and 12

TG: -51/-19***
tC:
+51/+19**
LDL:
+3.7/-1.6 ns
Very small LDL:
          
-18/+4**
HDL:
+11/-2.6****
BW:
-10.5/-5.5***
Glucose:
-12/-2**
Insulin:
-50/-19*
HOMA:
-55/-18**

 

High quality
Detailed analyses of a large number of lipid and metabolic parameters. Allrelevant measures, including most of the lipids, were in favour of thelowcarb diet in spite of a much higher intake of SFA. The significantdifference between  very smallLDL is particularly interesting because this fraction is a much sstrongerrisk marker for CVD than tC and LDL-C

Publicerad i Dokument