Peer-reviewed publication · Humans · In the living system
In a small phase 1 study, oral carbohydrate-derived fulvic acid produced no serious adverse events over exposures of a week or less.
- Oral
- Carbohydrate-derived fulvic acid
Over exposures of a week or less in 21 men, no serious adverse events were reported; mild gut and throat effects clustered at the top dose and one participant's liver enzymes rose and returned to normal, so this short study cannot speak to longer use.
Gandy et al., 17 February 2012. Clinical Pharmacology: Advances and Applications 4:7 to 11.
Scope, material and route
- Studied
- Men aged 18 or over with pollen allergy, otherwise healthy and not on anti-allergy treatment; women excluded
- Design
- Three stages in the same volunteers: single-dose escalation and a three-day repeated-dose stage in two randomised groups of 15, then a seven-day double-blind, placebo-controlled crossover
- Material
- Carbohydrate-derived fulvic acid, 3.8 percent, described as heavy-metal free and, in the treatment section, as given in syrup; the manufacturer and production method are not stated
- Route
- Oral, taken without food
- Exposure
- Single doses of 5 and 20 mL (group A) or 10 and 40 mL (group B); then 20 mL (A) or 40 mL (B) twice daily for 3 days; then 40 mL twice daily or placebo for 7 days each, with a washout between. Study exposure, not application guidance.
- Duration
- Seven days at most for any exposure; the washout is given as one week in the abstract and treatment section and as two weeks in the methods
Study design
Stage 1: single doses
Two randomised groups: 5 and 20 mL (group A), or 10 and 40 mL (group B).
30 menEnrolled, in two groups of 15.
Stage 2: three days
20 mL (group A) or 40 mL (group B), twice daily for three days.
Stage 3: crossover
40 mL twice daily or placebo for seven days each, double-blind, with a washout between (one week in the abstract, two in the methods).
21 menCompleted.
- Did not complete9 of 30: 4 for non-compliance, 1 adverse event (hypertension, judged unrelated), 4 withdrawn for heart findings present at baseline
More study details
- Research question
- Is oral carbohydrate-derived fulvic acid safe over the anticipated dose range, and does it show a sign of anti-inflammatory activity worth further study?
- Sample size
- 30 enrolled; 21 completed
- Comparator
- Placebo in the crossover stage only; its composition is not described
- Outcomes measured
- Vital signs, physical examination, health questionnaire, electrocardiogram, full blood count, liver and kidney function; skin-prick wheal diameter for each participant's most reactive allergen
Findings
Researchers at the University of Pretoria gave 30 men with pollen allergy an oral 3.8 percent carbohydrate-derived fulvic acid in three stages: single doses from 5 to 40 mL, then 20 or 40 mL twice daily for three days, then 40 mL twice daily or placebo for seven days in a double-blind crossover. Twenty-one completed. The authors report that blood counts and liver and kidney measures stayed within normal limits, apart from one transient liver enzyme rise they attributed to a likely viral infection, and that no serious adverse events occurred. Diarrhoea, sore or burning throat, headache and malaise were reported, mostly at 40 mL twice daily, and judged mild and transient. Skin-prick wheals shrank more on fulvic acid than on placebo. The study was small, short, in men only, and states no funding source.
| Outcome | Comparison or result | Interpretation |
|---|---|---|
| Serious adverse events | None reported | No serious harm detected in this small, short study |
| Blood, liver and kidney measures | Reported as within normal limits; one participant had raised liver enzymes after 40 mL, attributed by the authors to a likely viral infection, which returned to normal | One transient abnormal result, attributed by the authors to another cause; no pattern across participants is reported |
| Side effects | Diarrhoea, sore or burning throat, headache, malaise, nausea, appetite suppression and abdominal discomfort, mostly at 40 mL twice daily | Judged mild and transient; the authors link them to the product's low pH. No placebo comparison of side effects is reported |
| Withdrawals | 9 of 30 did not complete: 4 for non-compliance, 1 adverse event (hypertension, judged unrelated) and 4 withdrawn for arrhythmia or bradycardia present at baseline | Under a third lost; the paper does not explain how heart findings present at baseline passed screening |
| Skin-prick wheal diameter, crossover | 6.63 to 4.97 mm on fulvic acid against 7.03 to 6.73 mm on placebo (P < 0.05); smaller wheal in 81 against 62 percent of participants | One immune-response measure; no exact P value or confidence interval reported |
Wheal values are means before and after each seven-day crossover period, as reported. Values are extracted from the source as reported; no raw data were available.
Interpretation and limits
What this record supports
No serious adverse events in 21 men taking up to 40 mL of this 3.8 percent preparation twice daily for up to a week. Blood measures were reported within normal limits apart from one participant's liver-enzyme rise, which the authors attributed to a likely viral infection and which returned to normal, and mild gut and throat effects clustered at the top dose. It says nothing about longer use.
What remains uncertain
- Size and exposure. 21 completers, men only, and nothing longer than seven days; rare or longer-term effects could not be detected.
- Efficacy. The authors call the wheal result anti-inflammatory and evidence of absorption; it is one skin-test measure in a small crossover, and blood levels were not measured.
- Reporting. The washout is given as one week and as two weeks, the analysis as covariance and as variance, and placebo composition and crossover order are not described.
- Extrapolation. The authors' conclusion that 15 mL daily is safe rests on these short exposures and earlier animal work, not on long-term human data.
- Material. A carbohydrate-derived fulvic acid; the result does not transfer to humic and fulvic materials from soil or lignite.
Which part of the framework it informs
Environmental conditions
The physical, chemical and management context.
Microbial activity
What microbial communities do within that context.
Observable function
What can be observed or measured in the host or wider system.
This record informs this area.
Source, funding and review
- Source type
- Peer-reviewed publication
- Associated products
- This record does not assess an associated product.
- Funding and relationships
- No funding source is stated in the article. The authors report no conflicts of interest, and all four list the Department of Pharmacology, University of Pretoria. The paper does not name the manufacturer, refers to the manufacturer's dosing recommendation, and does not say whether any author had a relationship with it.
- Review status
- Prepared as an editorial summary. External scientific review has not been completed.
- What was read
- Full text read through Europe PMC (PMC3304339), including the four figures as published images. The publisher's page showed the abstract only.
- Original title
- Phase 1 clinical study of the acute and subacute safety and proof-of-concept efficacy of carbohydrate-derived fulvic acid
- Authors
- Gandy JJ, Meeding JP, Snyman JR, van Rensburg CEJ
- Publication
- Clinical Pharmacology: Advances and Applications 4:7 to 11, 17 February 2012
- DOI
- 10.2147/CPAA.S25784
- Summary prepared by
- Carbon Biome Project
- Date added
- 19 October 2026
- Cite this summary
- Carbon Biome Project. In a small phase 1 study, oral carbohydrate-derived fulvic acid produced no serious adverse events over exposures of a week or less. Evidence library record, added 19 October 2026. carbonbiomeproject.com/evidence/gandy-2012-oral-fulvic-acid-phase-1-safety/
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