CLINICAL TRIAL | PEER REVIEWED PUBLICATION

Randomized Trial to Assess the Safety and Tolerability of Daily Intake of an Allulose Amino Acid-Based Hydration Beverage in Men and Women

The aim of this study was to determine the safety and tolerability of Liquid I.V. Sugar-Free in healthy non-obese participants.

Intervention:

Liquid I.V. Sugar-Free: 1 stick/day (n = 10), 2 sticks/day (n = 10), 3 sticks/day (n = 10) or placebo.

Each stick of Liquid I.V. contained 8–9 g allulose, L-alanine and L-glutamine, ~510 mg sodium, ~380 mg potassium plus vitamins B3, B5, B6, B12, C.

Participants mixed each stick into 16 oz water and consumed daily.

Placebo: flavor-matched, sugar-free Crystal Light.

Study Duration: 4 weeks

Eligibility Criteria:

Healthy male and female subjects aged 18 – 50 years.
Body mass index (BMI) between 18 and 29.9 kg/m².
Able to fast overnight.

For more, plus the exclusion criteria, see:

ClinicalTrials.gov

	1 stick/day	2 sticks/day	3 sticks/day	Placebo
Liver function
Aspartate aminotransferase (AST) (IU/L) Visit 1 Visit 2 Visit 3	19.60 (6.08) 18.90 (7.78) 17.60 (4.09)	19.40 (3.66) 20.30 (4.90) 21.00 (7.27)	17.00 (4.55) 19.20 (3.52) 23.00 (16.46)	21.00 (7.42) 21.44 (6.04) 20.80 (7.67)
Alanine Transaminase (ALT) (IU/L) Visit 1 Visit 2 Visit 3	17.50 (8.75) 16.80 (16.69) 13.30 (4.50)	13.90 (3.67) 13.70 (5.46) 15.80 (6.81)	13.00 (3.68) 15.60 (3.34) 15.70 (7.82)	15.00 (4.60) 17.22 (7.48) 17.30 (6.83)
Alkaline Phosphatase (ALP) (IU/L) Visit 1 Visit 2 Visit 3	59.00 (13.20) 54.80 (15.22) 56.50 (16.70)	64.70 (16.01) 59.70 (18.01) 58.10 (14.96)	60.00 (17.24) 55.50 (15.97) 53.60 (15.99)	62.00 (14.40) 62.56 (15.35) 63.00 (16.79)
Kidney function
Creatinine (mg/dL) Visit 1 Visit 2 Visit 3	0.83 (0.25) 0.85 (0.25) 0.83 (0.24)	0.89 (0.19) 0.82 (0.17) 0.85 (0.12)	0.91 (0.26) 0.85 (0.21) 0.90 (0.23)	0.82 (0.20) 0.74 (0.15) 0.78 (0.14)
Albumin (g/dL) Visit 1 Visit 2 Visit 3	4.61 (0.35) 4.45 (0.21) 4.48 (0.30)	4.50 (0.29) 4.50 (0.23) 4.52 (0.43)	4.55 (0.36) 4.62 (0.33) 4.46 (0.29)	4.63 (0.20) 4.52 (0.15) 4.51 (0.29)
Blood urea nitrogen (BUN) (mg/dL) Visit 1 Visit 2 Visit 3	12.70 (4.11) 11.50 (4.09) 13.00 (3.71)	14.10 (2.89) 14.20 (3.08) 14.40 (4.01)	13.40 (3.84) 14.30 (2.63) 15.00 (4.76)	12.40 (3.81) 11.56 (3.54) 12.60 (3.10)
Vitals
Systolic blood pressure (mmHg) Visit 1 Visit 2 Visit 3	116 (7) 112 (10) 111 (11)	106 (8) 109 (6) 111 (10)	111 (12) 112 (10) 116 (11)	111 (10) 104 (10) 108 (8)
Diastolic blood pressure (mmHg) Visit 1 Visit 2 Visit 3	76 (3) 70 (3) 71 (5)	64 (7) 67 (7) 65 (9)	69 (9) 70 (7) 72 (8)	71 (7) 69 (10) 69 (9)
Heart rate (bpm) Visit 1 Visit 2 Visit 3	78 (10) 78 (12) 74 (8)	67 (8) 65 (8) 66 (6)	69 (13) 67 (11) 66 (13)	73 (14) 71 (19) 72 (13)
Metabolism
Fasted glucose (mg/dL) Visit 1 Visit 2 Visit 3	89.90 (5.22) 90.80 (13.42) 89.20 (8.89)	86.30 (6.00) 88.00 (5.72) 85.00 (6.46)	84.90 (5.97) 85.50 (7.41) 83.50 (4.25)	90.20 (8.74) 88.67 (9.42) 86.40 (8.33)

Conclusions

This clinical trial demonstrates that Liquid I.V. Sugar-Free was well-tolerated at all test levels and safe for human consumption.

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THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.

This information is provided as a medical and scientific educational resource for the use of dieticians and other licensed healthcare professionals. This information is intended for Practitioners to use as the basis for determining whether to recommend these products to their clients. All recommendations regarding protocols, dosing, prescribing and/or use instructions should be tailored to the individual needs of the client considering their medical history and concomitant therapies. This Information is not intended for use by consumers.