Background
Methods
Study design
Nutrient | Study Formula, target values | ||
---|---|---|---|
Controla | EHFa,b | AAF | |
Total Protein, gc | 2.8 | 2.4 | – |
Protein Equivalent, gd | – | – | 2.4 |
Total Fat, ge | 5.3 | 5.3 | 5.3 |
Linoleic acid, mg | 860 | 860 | 860 |
α-Linolenic acid, mg | 80 | 80 | 80 |
ARA, mg | 34 | 34 | 34 |
DHA, mg | 17 | 17 | 17 |
Total Carbohydrate, gf | 10.3 | 10.7 | 10.7 |
Vitamin A, IU | 300 | 300 | 300 |
Vitamin D, IU | 50 | 50 | 50 |
Vitamin E, IU | 2 | 2 | 2 |
Vitamin K, mcg | 9 | 9 | 8 |
Thiamin, mcg | 80 | 80 | 80 |
Riboflavin, mcg | 90 | 90 | 90 |
Vitamin B6, mcg | 60 | 60 | 60 |
Vitamin B12, mcg | 0.3 | 0.3 | 0.3 |
Niacin, mcg | 1000 | 1000 | 1000 |
Folic Acid, mcg | 16 | 16 | 16 |
Pantothenic Acid, mcg | 500 | 500 | 500 |
Biotin, mcg | 3 | 3 | 3 |
Vitamin C, mg | 12 | 12 | 12 |
Choline, mg | 24 | 24 | 24 |
Inositol, mg | 17 | 17 | 17 |
Calcium, mg | 94 | 94 | 94 |
Phosphorus, mg | 52 | 52 | 52 |
Magnesium, mg | 8 | 8 | 11 |
Iron, mg | 1.8 | 1.8 | 1.8 |
Zinc, mg | 1 | 1 | 1 |
Manganese, mcg | 25 | 25 | 60 |
Copper, mcg | 75 | 75 | 75 |
Iodine, mcg | 15 | 15 | 15 |
Selenium, mcg | 2.8 | 2.8 | 2.8 |
Sodium, mg | 47 | 41 | 43 |
Potassium, mg | 110 | 104 | 110 |
Chloride, mg | 86 | 81 | 79 |
Study objectives and outcomes
Statistical methods
Results
Participants
Study Group | Overall | |||
---|---|---|---|---|
Control | EHF | AAF | P | |
Total number of participants | 173 | 170 | 159 | 0.935 |
males/females, n | 101/72 | 96/74 | 91/68 | |
malesa | ||||
Weight (g) | 3730.9 ± 44.3 | 3689.8 ± 45.4 | 3684.7 ± 46.6 | 0.729 |
Length (cm) | 52.7 ± 0.2 | 52.5 ± 0.2 | 52.4 ± 0.2 | 0.638 |
Head circumference (cm) | 36.4 ± 0.1 | 36.1 ± 0.1 | 36.2 ± 0.1 | 0.304 |
femalesa | ||||
Weight (g) | 3482.7 ± 45.8 | 3626.7 ± 45.2 | 3554.1 ± 47.1 | 0.084 |
Length (cm) | 51.5 ± 0.2 | 52.0 ± 0.2 | 51.5 ± 0.2 | 0.176 |
Head circumference (cm) | 35.5 ± 0.1† | 36.0 ± 0.1 | 35.6 ± 0.1 | 0.013† |
Growth
Growth ratea | ||||
---|---|---|---|---|
Day | Group (n) | Weight (g/day) | Length (cm/day) | Head circumference (cm/day) |
male | ||||
30 | Control (90) | 35.3 ± 1.3 | 0.14 ± 0.008 | 0.076 ± 0.004*† |
EHF (80) | 37.8 ± 1.4 | 0.13 ± 0.009 | 0.091 ± 0.004 | |
AAF (82) | 39.7 ± 1.4 | 0.13 ± 0.009 | 0.098 ± 0.004 | |
60 | Control (78) | 33.2 ± 1.0 | 0.12 ± 0.004 | 0.067 ± 0.002† |
EHF (67) | 34.7 ± 1.1 | 0.13 ± 0.004 | 0.071 ± 0.002 | |
AAF (67) | 36.4 ± 1.1 | 0.13 ± 0.004 | 0.076 ± 0.002 | |
90 | Control (74) | 30.5 ± 0.8 | 0.11 ± 0.002 | 0.060 ± 0.001† |
EHF (60) | 31.7 ± 0.9 | 0.12 ± 0.003 | 0.060 ± 0.002† | |
AAF (64) | 33.0 ± 0.9 | 0.12 ± 0.003 | 0.067 ± 0.001 | |
120 | Control (71) | 28.6 ± 0.7 | 0.11 ± 0.002 | 0.054 ± 0.001† |
EHF (57) | 29.5 ± 0.8 | 0.11 ± 0.002 | 0.054 ± 0.001† | |
AAF (63) | 30.5 ± 0.7 | 0.11 ± 0.002 | 0.059 ± 0.001 | |
female | ||||
30 | Control (62) | 31.6 ± 1.3 | 0.12 ± 0.009 | 0.075 ± 0.004 |
EHF (58) | 33.0 ± 1.4 | 0.14 ± 0.009 | 0.077 ± 0.005 | |
AAF (59) | 32.9 ± 1.3 | 0.13 ± 0.009 | 0.081 ± 0.005 | |
60 | Control (55) | 28.3 ± 1.0 | 0.11 ± 0.004 | 0.063 ± 0.002 |
EHF (52) | 28.1 ± 1.0 | 0.12 ± 0.004 | 0.063 ± 0.002 | |
AAF (50) | 29.8 ± 1.0 | 0.11 ± 0.004 | 0.069 ± 0.002 | |
90 | Control (49) | 26.0 ± 0.9 | 0.11 ± 0.003 | 0.055 ± 0.002 |
EHF (50) | 25.7 ± 0.9 | 0.11 ± 0.003 | 0.054 ± 0.002 | |
AAF (49) | 26.8 ± 0.9 | 0.11 ± 0.003 | 0.058 ± 0.002 | |
120 | Control (45) | 24.8 ± 0.8 | 0.10 ± 0.002 | 0.050 ± 0.001 |
EHF (49) | 24.2 ± 0.8 | 0.10 ± 0.002 | 0.049 ± 0.001 | |
AAF (46) | 25.1 ± 0.8 | 0.10 ± 0.002 | 0.050 ± 0.001 |
Tolerance
Fussiness, n (%) | Gassiness, n (%) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Day | Group | Not at all | Slightly | Moderately | Very | Extremely | P | None at all | Slight amount | Moderate amount | Excessive amount | P |
14 | Control | 43 (25) | 90 (52) | 34 (20) | 4 (2) | 2 (1) | 0.513 | 11 (6) | 75 (43) | 73 (42) | 14 (8) | 0.791 |
EHF | 52 (31) | 85 (50) | 26 (15) | 6 (4) | 1 (1) | 12 (7) | 72 (42) | 73 (43) | 13 (8) | |||
AAF | 40 (25) | 81 (51) | 34 (22) | 1 (1) | 2 (1) | 14 (9) | 64 (41) | 72 (46) | 8 (5) | |||
30 | Control | 16 (11) | 67 (48) | 43 (30) | 14 (10) | 1 (1) | 0.029*† | 9 (6) | 59 (42) | 64 (45) | 9 (6) | 0.611 |
EHF | 21 (17) | 66 (54) | 30 (25) | 4 (3) | 1 (1) | 4 (3) | 56 (46) | 51 (41) | 12 (10) | |||
AAF | 22 (18) | 60 (49) | 37 (30) | 2 (2) | 2 (2) | 9 (7) | 54 (44) | 51 (41) | 9 (7) | |||
60 | Control | 30 (24) | 57 (45) | 32 (25) | 5 (4) | 2 (2) | 0.171 | 11 (9) | 49 (39) | 51 (40) | 15 (12) | 0.294 |
EHF | 36 (32) | 52 (46) | 21 (19) | 3 (3) | 1 (1) | 8 (7) | 55 (49) | 44 (39) | 6 (5) | |||
AAF | 28 (25) | 53 (46) | 26 (23) | 5 (4) | 2 (2) | 7 (6) | 56 (49) | 46 (40) | 5 (4) | |||
90 | Control | 46 (38) | 55 (45) | 19 (16) | 0 (0) | 1 (1) | 0.874 | 19 (16) | 60 (50) | 37 (31) | 5 (4) | 0.850 |
EHF | 45 (43) | 40 (38) | 15 (14) | 3 (3) | 2 (2) | 12 (11) | 56 (53) | 32 (30) | 5 (5) | |||
AAF | 39 (35) | 54 (48) | 15 (13) | 4 (4) | 0 (0) | 18 (16) | 55 (49) | 29 (26) | 10 (9) | |||
120 | Control | 51 (44) | 41 (35) | 17 (15) | 6 (5) | 1 (1) | 0.192 | 25 (22) | 52 (45) | 35 (30) | 4 (3) | 0.783 |
EHF | 49 (47) | 41 (39) | 10 (10) | 4 (4) | 1 (1) | 21 (20) | 57 (54) | 24 (23) | 3 (3) | |||
AAF | 35 (33) | 46 (43) | 20 (19) | 5 (5) | 0 (0) | 25 (24) | 47 (44) | 32 (30) | 2 (2) |
Stool | Overall | Stool consistency, n (%) | Overall | ||||||
---|---|---|---|---|---|---|---|---|---|
Day | Group (n) | frequencyb | P | hard | formed | soft | Unformed or seedy | watery | P |
14 | Control (173) | 2.9 ± 0.2 | 0.352 | 3 ( 2) | 5 (3 ) | 67 (40) | 87 (52) | 6 (4) | 0.679 |
EHF (170) | 3.3 ± 0.2 | 2 (1) | 8 (5) | 74 (45) | 76 (46) | 6 (4) | |||
AAF (156) | 3.2 ± 0.2 | 2 (1) | 4 (3) | 69 (45) | 75 (49) | 4 (3) | |||
30 | Control (140) | 3.6 ± 0.2 | < 0.001*† | 3 (2) | 5 (4) | 74 (53) | 53 (38) | 5 (4) | < 0.001*† |
EHF (121) | 3.4 ± 0.2 | 1 (1) | 5 (4) | 67 (54) | 46 (37) | 4 (3) | |||
AAF (123) | 2.5 ± 0.2 | 21 (18) | 43 (36) | 48 (40) | 7 (6) | 0 (0) | |||
60 | Control (125) | 3.0 ± 0.1 | < 0.001*‡ | 1 (1) | 3 (2) | 67 (54) | 47 (38) | 6 (5) | < 0.001*† |
EHF (113) | 2.5 ± 0.1 | 0 (0) | 3 (3) | 58 (53) | 42 (38) | 7 (6) | |||
AAF (114) | 2.2 ± 0.1 | 8 (7) | 27 (25) | 62 (56) | 11 (10) | 2 (2) | |||
90 | Control (121) | 2.5 ± 0.1 | 0.008*† | 0 (0) | 3 (3) | 66 (58) | 33 (29) | 12 (11) | < 0.001*† |
EHF (104) | 2.5 ± 0.2 | 0 (0) | 6 (6) | 55 (54) | 38 (37) | 3 (3) | |||
AAF (112) | 1.9 ± 0.1 | 4 (4) | 19 (17) | 74 (67) | 12 (11) | 1 (1) | |||
120 | Control (116) | 2.4 ± 0.1 | 0.356 | 2 (2) | 6 (5) | 64 (57) | 34 (30) | 7 (6) | < 0.001*† |
EHF (105) | 2.3 ± 0.1 | 1 (1) | 6 (6) | 65 (63) | 30 (29) | 2 (2) | |||
AAF (105) | 2.1 ± 0.1 | 5 (5) | 24 (23) | 65 (63) | 10 (10) | 0 (0) |
Day | Group | males, n | Mean ± SE | Overall | females, n | Mean ± SE | Overall |
---|---|---|---|---|---|---|---|
P | P | ||||||
30 | Control | 84 | 27.1 ± 0.9 | 0.390 | 57 | 26.1 ± 0.7 | 0.976 |
EHF | 70 | 27.7 ± 1.0 | 53 | 26.3 ± 0.7 | |||
AAF | 70 | 28.9 ± 1.0 | 53 | 26.2 ± 0.7 | |||
60 | Control | 76 | 30.2 ± 1.0 | 0.017*† | 50 | 29.5 ± 1.0 | 0.556 |
EHF | 62 | 33.4 ± 1.1 | 51 | 29.6 ± 1.0 | |||
AAF | 66 | 34.2 ± 1.1 | 49 | 30.9 ± 1.0 | |||
90 | Control | 73 | 34.1 ± 1.0 | 0.247 | 48 | 30.6 ± 1.2 | 0.324 |
EHF | 56 | 33.1 ± 1.2 | 49 | 32.2 ± 1.2 | |||
AAF | 63 | 35.8 ± 1.1 | 49 | 33.2 ± 1.2 | |||
120 | Control | 71 | 36.4 ± 1.2 | 0.921 | 45 | 33.3 ± 1.2 | 0.222 |
EHF | 57 | 37.0 ± 1.4 | 48 | 35.3 ± 1.1 | |||
AAF | 61 | 37.0 ± 1.3 | 45 | 36.1 ± 1.2 |