ოთხშაბათი, აპრილი 15, 2026
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Global Ingredient Risk Index Amino Acids

Betaine Anhydrous

Also known as: Trimethylglycine, TMG, Betaine, Anhydrous betaine

LOW RISK 2.0/10 How?

This ingredient is classified as unclassified risk (GIRI score: 2.0/10).

02

Safety Profile

Information not yet available for this ingredient profile.

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03

Interactions

Information not yet available for this ingredient profile.

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04

Evidence and Scientific Findings

Overview

Ingredient Overview

Betaine anhydrous (trimethylglycine) is a methyl donor used for homocysteine reduction and sports performance. It is generally well tolerated. GI discomfort and body odour from TMAO production are common adverse effects at high doses (>3 g/day). It may increase LDL cholesterol at high doses. No significant drug interactions are documented at standard doses.

Classification

Biological and Chemical Classification

Information not yet available for this ingredient profile.

Mechanism

Mechanism of Action

Information not yet available for this ingredient profile.

Clinical Evidence

Clinical Evidence of Effectiveness

Information not yet available for this ingredient profile.

Pharmacokinetics

Pharmacokinetics

Information not yet available for this ingredient profile.

Dosage

Recommended Dosage

Information not yet available for this ingredient profile.

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05

SETI — Scientific Evidence Transparency Index

SETI Score 51/100
Risk Level High risk
Scientific Confidence Low
Evidence Strength Limited
Key Benefit Amino Acids
Evidence Reviewed 9 PubMed studies
Scientific Confidence Low
Based on study quality, consistency, and recency

Executive Summary — Ingredient Assessment

SETI Score 51/100
Risk Level High risk
Evidence Strength Limited
Main Benefit Amino Acids
Ingredient Betaine Anhydrous
Scientific Evidence Overview
  • 9 studies reviewed
  • 0 high-quality studies (meta-analysis or RCT)
  • Main clinical benefit observed: Amino Acids
  • Evidence consistency: High consistency across studies (100%)
Safety Signals
  • No significant safety signals identified in the reviewed literature.
Evidence Strength Limited
Final Scientific Assessment

The available scientific evidence for Betaine Anhydrous indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.

Ingredient Betaine Anhydrous
Evidence reviewed 9 peer-reviewed studies (last 10 years)
51 /100

Total SETI Score

High risk
Evidence quality 9/40
Evidence consistency 20/20
Safety signals 2/20
Study recency 10/10
Evidence transparency 10/10

Evidence Summary

  • 9 studies reviewed
  • 0 high-quality studies (meta-analysis or systematic review)
  • 0 studies identified benefits or no safety concern (GREEN)
  • 9 studies reported limited or advisory safety evidence (YELLOW)

Evidence Policy

Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.

Last updated: 26 მარ 2026, 14:06

Evidence Distribution

9 Other / unclassified
  1. Observational / other LOW evidence YELLOW
    Assessment of the feed additives betaine anhydrous (3a920) and betaine hydrochloride (3a925) for all animal species for the renewal of their authorisations… ↗
    PMID 40276164 ↗
    Journal EFSA J
    Year 2025
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/40276164/
    Villa RE et al.. Assessment of the feed additives betaine anhydrous (3a920) and betaine hydrochloride (3a925) for all animal species for the renewal of their authorisations (Orffa Additives B.V.).. EFSA J. 2025. PMID:40276164.
  2. Observational / other LOW evidence YELLOW
    The Impacts of Combined Blood Flow Restriction Training and Betaine Supplementation on One-Leg Press Muscular Endurance, Exercise-Associated Lactate Concentrations, Serum Metabolic Biomarkers,… ↗
    PMID 36501070 ↗
    Journal Nutrients
    Year 2022
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/36501070/
    Machek SB et al.. The Impacts of Combined Blood Flow Restriction Training and Betaine Supplementation on One-Leg Press Muscular Endurance, Exercise-Associated Lactate Concentrations, Serum Metabolic Biomarkers, and Hypoxia-Inducible Factor-1u03b1 Gene Expression.. Nutrients. 2022. PMID:36501070.
  3. Observational / other LOW evidence YELLOW
    Postauthorization safety study of betaine anhydrous. ↗
    PMID 35358327 ↗
    Journal J Inherit Metab Dis
    Year 2022
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/35358327/
    Mu00fctze U et al.. Postauthorization safety study of betaine anhydrous.. J Inherit Metab Dis. 2022. PMID:35358327.
  4. Observational / other LOW evidence YELLOW
    Human Serum Betaine and Associated Biomarker Concentrations Following a 14 Day Supplemental Betaine Loading Protocol and during a 28 Day Washout Period:… ↗
    PMID 35276860 ↗
    Journal Nutrients
    Year 2022
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/35276860/
    Machek SB et al.. Human Serum Betaine and Associated Biomarker Concentrations Following a 14 Day Supplemental Betaine Loading Protocol and during a 28 Day Washout Period: A Pilot Investigation.. Nutrients. 2022. PMID:35276860.
  5. Observational / other LOW evidence YELLOW
    Betaine anhydrous in homocystinuria: results from the RoCH registry. ↗
    PMID 30871635 ↗
    Journal Orphanet J Rare Dis
    Year 2019
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/30871635/
    Valayannopoulos V et al.. Betaine anhydrous in homocystinuria: results from the RoCH registry.. Orphanet J Rare Dis. 2019. PMID:30871635.
  6. Observational / other LOW evidence YELLOW
    Accumulation of Liver Lipids Induced by Vitamin B(6) Deficiency Was Effectively Ameliorated by Choline and, to a Lesser Extent, Betaine. ↗
    PMID 30814419 ↗
    Journal J Nutr Sci Vitaminol (Tokyo)
    Year 2019
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/30814419/
    Kitagawa E et al.. Accumulation of Liver Lipids Induced by Vitamin B(6) Deficiency Was Effectively Ameliorated by Choline and, to a Lesser Extent, Betaine.. J Nutr Sci Vitaminol (Tokyo). 2019. PMID:30814419.
  7. Observational / other LOW evidence YELLOW
    Safety and efficacy of betaine anhydrous for food-producing animal species based on a dossier submitted by AB Vista. ↗
    PMID 32625971 ↗
    Journal EFSA J
    Year 2018
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/32625971/
    Rychen G et al.. Safety and efficacy of betaine anhydrous for food-producing animal species based on a dossier submitted by AB Vista.. EFSA J. 2018. PMID:32625971.
  8. Observational / other LOW evidence YELLOW
    ISMP Medication Error Report Analysis: Betaine Anhydrous Versus Betaine Hydrochloride Look-Alike Generic Names Don't Give Zurampic Without Allopurinol Lantus Overdose Tied to… ↗
    PMID 28439129 ↗
    Journal Hosp Pharm
    Year 2017
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/28439129/
    Cohen MR et al.. ISMP Medication Error Report Analysis: Betaine Anhydrous Versus Betaine Hydrochloride Look-Alike Generic Names Don't Give Zurampic Without Allopurinol Lantus Overdose Tied to Confusing Vial Label More on Lipid Rescue.. Hosp Pharm. 2017. PMID:28439129.
  9. Observational / other LOW evidence YELLOW
    Choline and betaine ameliorate liver lipid accumulation induced by vitamin B(6) deficiency in rats. ↗
    PMID 27696964 ↗
    Journal Biosci Biotechnol Biochem
    Year 2017
    Study type Observational / other
    Evidence strength LOW evidence
    PubMed link https://pubmed.ncbi.nlm.nih.gov/27696964/
    Kitagawa E et al.. Choline and betaine ameliorate liver lipid accumulation induced by vitamin B(6) deficiency in rats.. Biosci Biotechnol Biochem. 2017. PMID:27696964.
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06

Score Transparency

Q × L × D × S × 10 = 2.0 / 10

The GIRI Score is the product of four independently computed evidence components, each normalised to 0–1, then scaled to 0–10. Every component is derived exclusively from peer-reviewed references and regulatory data — no editorial judgement is applied.

Q
Evidence Quantity 0 / 10
0%

0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.

Method: Q = number of approved references ÷ 10 (capped at 1.0)

L
Evidence Quality 5 / 10
50%

Limited — mostly case reports or animal studies

Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.

D
Evidence Direction 5 / 10
Benefit
Risk
50%

Mixed or neutral — roughly equal benefit and risk signals

Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.

S
Safety Signals 5 / 10
50%

One or more monitoring-level safety signals active

Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.

0Q × 5L × 5D × 5S = 2.0 / 10

Final GIRI Score for Betaine Anhydrous. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.

Full methodology & data sources

The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.

  • References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
  • Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
  • Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
  • Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
07

Risk Level Classification

LOW RISK 2.0/10

Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.

LOW
0–3.0
MODERATE
3.0–5.5
HIGH
5.5–7.5
CRITICAL
7.5–10
2.0

The score pin shows exactly where this ingredient falls on the fixed risk scale.

What drove the Low classification for Betaine Anhydrous

GIRI Score 2.0 / 10

A score of 2.0 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.

Evidence Quantity (Q) 0 / 10 refs

0 approved references.

Evidence Quality (L) 50%

Limited — mostly case reports or animal studies (Level 4–5).

Evidence Direction (D) 50% toward risk

Neutral or mixed — benefit and risk signals roughly balanced.

Safety Signals (S) 0 active signals

No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.

Regulatory Status No restrictions found

No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).

How are the Low / Moderate / High / Critical thresholds defined?

The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:

LevelScoreMeaning
LOW0.0 – 2.9Sparse or predominantly beneficial evidence. No active safety alerts.
MODERATE3.0 – 5.4Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups.
HIGH5.5 – 7.4Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended.
CRITICAL7.5 – 10Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision.

Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.

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