Introduction
Methods
Study design and participants
Anthropometrics measurements
Body composition measurements
Laboratory measurements
Food intake measurements
Covariates
Statistical analysis
Results
Population characteristics
B-PROOF participants (N = 2919) | DXA-test participants (N = 1227) | FFQ participants (N = 603) | |
---|---|---|---|
Age (years)a | 74 (6.5) | 72.9 (5.7) | 72.8 (5.7) |
Sex | |||
Female (%) | 50 | 48.3 | 42.1 |
Body mass index (kg/m2)a | 27.1 (4.0) | 27.0 (3.8) | 26.9 (3.6) |
Underweight (%) | 0.4 | 0.2 | 0.3 |
Normal weight (%) | 28.6 | 30.4 | 28.4 |
Overweight (%) | 50.9 | 50.1 | 54.7 |
Overweight (%) | 20.1 | 19.2 | 16.6 |
Fat | NA | NA | |
Total fat mass (kg) | 25.5 (8.4) | ||
Total fat percentage (%) | 32.4 | ||
FMI (kg/m2) | 8.9 (3.2) | ||
FFMI (kg/m2) | 18.0 (2.2) | ||
Smoking (%) | |||
Current | 56.5 | 57.6 | 58.8 |
Former | 9.6 | 9.0 | 10.4 |
Never | 33.9 | 33.3 | 31.0 |
Alcohol intake (%) | |||
Light | 67.4 | 64.1 | 64.2 |
Moderate | 28.8 | 31.4 | 32.8 |
Excessive | 3.4 | 4.0 | 2.5 |
Very excessive | 0.4 | 0.6 | 0.5 |
Self-reported medical history of | |||
Cardiac disease (% yes) | 25.1 | 25 | 25.5 |
Diabetes (% yes) | 10.3 | 10.8 | 7.1 |
Hypercholesterolemia (%yes) | 24.7 | 28.5 | 21.2 |
Measured hypertension (%yes) | 51.5 | 58.8 | 38.6 |
Homocysteine (mmol/L)b | 14.4 [3.4] | 14.3 [3.2] | 14.0 [3.2] |
Serum folate (nmol/L)a | 21.0 (11.62) | 21.3 (9.3) | 20.1 (17.2) |
Serum vitamin-B12 (pmol/L)a | 285.5 (116.0) | 287.5 (115.2) | 281.2 (107.9) |
Holotranscobalamin (pmol/L)b | 64.0 [251.0] | 67.0 [41.0] | 60.0 [34.0] |
MMA (µgmol/L)b | 0.2 [0.1] | 0.2 [0.1] | 0.2 [0.1] |
MTHFR (%) | |||
CC | 44.9 | 46.4 | 44.3 |
CT | 42.1 | 40.8 | 42.6 |
TT | 13.0 | 12.8 | 13.1 |
Folic acid supplement use (%) | 16.0 | 16.3 | 11.1 |
Vitamin-B12 supplement use (%) | 16.2 | 16.8 | 11.1 |
Folate intake from food (mcg/day)a | NA | NA | 191.5 (53.9) |
Vitamin-B12 intake from food (mcg/day)a | NA | NA | 4.1 (2.0) |
Total activity (Kcal/day)b | 560 [489] | 595 [504] | 593 [506] |
Total energy intake (Kcal/day)a | NA | NA | 2006 (473) |
Education (%) | |||
Low | 32.1 | 32.5 | 25.9 |
Middle | 42.0 | 41.1 | 40.8 |
High | 26.0 | 26.4 | 33.3 |
Region (%) | |||
Amsterdam | 26.6 | 34.6 | 0 |
Rotterdam | 29.4 | 65.4 | 0 |
Wageningen | 44.0 | 0 | 100 |
Baseline associations of vitamin B12 and folic acid with body composition
BMI | ||
---|---|---|
Model 1 | Model 2 | |
β 95% CI | β 95% CI | |
Serum folate (nmol/L) (n = 2919) | − 0.018 [− 0.030; − 0.005]* | − 0.021 [− 0.039; − 0.004]* |
Serum vitamin-B12 (pmol/L) (n = 2919) | − 0.001 [− 0.003; − 0.00001]* | − 0.001 [− 0.002; 0.001] |
HoloTC_loga (pmol/L) (n = 2919) | 0.533 [− 0.085; 1.151] | 0.612 [− 0.099; 1.323] |
MMA (μgmol/L) (n = 2919) | − 0.258 [− 0.742; 0.225] | − 0.675 [− 1.470; 0.120] |
Folic acid supplement use (n = 2919) | − 0.271 [− 0.666; 0.124] | − 0.104 [− 0.543; 0.335] |
Vitamin-B12 supplement use (n = 2919) | − 0.366 [− 0.758; 0.026] | − 0.268 [− 0.705; 0.169] |
Folic acid total intake (FFQ) (n = 1227) | − 0.0002 [− 0.002; 0.001] | 0.0005 [− 0.003; 0.002] |
Vitamin-B12 total intake (FFQ)a (n = 1227) | − 0.795 [− 2.086; 0.496] | − 1.045 [− 2.735; 0.646] |
Folic acid intake from food (FFQ) (n = 1227) | 0.005 [− 0.002; 0.011] | 0.007 [− 0.001; 0.015] |
Vitamin-B12 total intake from food (FFQ) (n = 1227) | 0.033 [− 0.013; 0.080] | 0.069 [− 0.006; 0.143] |
FMI | FFMI | |||
---|---|---|---|---|
Model 1 | Model 2 | Model 1 | Model 2 | |
β 95% CI | β 95% CI | β 95% CI | β 95% CI | |
Serum folate (nmol/L) | − 0.002 [− 0.019; 0.016] | − 0.002 [-0.019; 0.016] | − 0.009 [− 0.020; 0.002] | − 0.010 [− 0.021; 0.0005] |
Serum vitamin-B12 (pmol/L) | 0.0002 [− 0.002; 0.001] | − 0.000003 [− 0.001; 0.001] | 0.0001 [− 0.001; 0.001] | 0.0003 [− 0.001; 0.001] |
HoloTC_loga (pmol/L) | 0.748 [0.073; 1.423]* | 0.955 [0.262; 1.647]* | 0.232 [− 0.191; 0.654] | 0.403 [− 0.032; 0.839] |
MMA (μgmol/L) | − 0.746 [− 1.530; 0.039] | − 1.108 [− 1.899; − 0.316]* | − 0.138 [− 0.629; 0.353] | − 0.170 [− 0.669; 0.328] |
Folic acid supplements | − 0.031 [− 0.462; 0.400] | 0.174 [− 0.272; 0.621] | − 0.175 [− 0.444; 0.094] | − 0.105 [− 0.384; 0.174] |
Vitamin-B12 supplements | − 0.184 [− 0.610; 0.242] | − 0.054 [− 0.494; 0.386] | − 0.191 [− 0.457; 0.075] | − 0.112 [− 0.388;0.163] |
The effect of the intervention
Intervention group | Placebo group | |||||||
---|---|---|---|---|---|---|---|---|
Baseline estimated mean (SD) | FU estimated mean (SD) | 2-year change | Baseline estimated mean (SD) | FU estimated mean (SD) | 2-year change | Treatment effect on FU β 95% CI | Treatment effect on ∆ BC β 95% CI | |
BMI (n = 2919) | 27.116 (3.975) | 27.158 (4.229) | 0.042 | 27.171 (3.959) | 27.207 (4.008) | 0.049 | − 0.051 [− 0.368; 0.265] | − 0.031 [− 0.156; 0.093] |
FMI (n = 1227) | 8.951 (3.201) | 9.120 (3.244) | 0.169 | 8.929 (3.227) | 8.975 (3.110) | 0.046 | 0.105 [− 0.270; 0.479] | 0.015 [− 0.101; 0.130] |
FFMI (n = 1227) | 17.979 (2.150) | 17.976 (2.182) | − 0.003 | 18.057 (2.273) | 17.951 (2.172) | − 0.106 | 0.039 [− 0.220; 0.298] | 0.052 [− 0.073; 0.177] |