Caralluma Fimbriata: Is This Appetite Suppressant Safe?
Quick Summary: Researchers studied a Caralluma fimbriata extract, often used for weight loss, to see if it was safe. The study found no signs of toxicity or harmful effects in lab tests and animal studies, suggesting it's safe at certain doses.
Is Caralluma Fimbriata Safe? Study Results
This research looked at the safety of a Caralluma fimbriata extract, a plant sometimes used in weight loss supplements. The study found no evidence of harm in lab tests or animal studies. This means the extract didn't cause genetic damage or other health problems in the doses tested.
What The Research Found
The study used different methods to check the extract's safety:
- Lab Tests: They tested the extract to see if it caused changes in cells that could lead to cancer. The tests showed no harmful effects.
- Animal Study (Rats): Rats were given the extract daily for six months. Even at the highest dose, there were no signs of illness or toxicity.
- Pregnancy Study (Rats): Pregnant rats were given the extract. There were no problems with the mothers or their developing babies.
Study Details
- Who was studied: Lab cells and rats.
- How long: Lab tests were short-term. The animal study lasted 6 months. The pregnancy study lasted through the pregnancy period.
- What they took: Rats received the Caralluma fimbriata extract by mouth at different doses.
What This Means For You
- Potential Safety: This study suggests that the Caralluma fimbriata extract used in the study is likely safe at the doses tested.
- More Research Needed: This study was done on animals. More research is needed to confirm these findings in humans.
- Talk to Your Doctor: Always talk to your doctor before taking any new supplements, including Caralluma fimbriata, especially if you are pregnant or have any health conditions.
Study Limitations
- Animal Studies: Results from animal studies don't always apply to humans.
- Long-Term Effects: The study didn't look at the long-term effects of taking the extract.
- Specific Extract: The study only tested one specific type of Caralluma fimbriata extract. Other products may have different results.
- Human Trials Needed: The study did not involve human participants.
Technical Analysis Details
Key Findings
The study concluded that a hydroethanolic extract of Caralluma fimbriata (CFE) demonstrated no genotoxic, chronic, or developmental toxicity in preclinical models. In vitro assays (Ames test and chromosomal aberration test) showed no mutagenic or clastogenic effects at concentrations up to 5000 μg/plate or mL. A 6-month oral toxicity study in rats found no deaths or treatment-related toxicity at doses up to 1000 mg/kg body weight/day, establishing this as the no observed adverse effect level (NOAEL). A prenatal developmental toxicity study also revealed no maternal or fetal abnormalities at doses up to 1000 mg/kg.
Study Design
This was a preclinical toxicological study conducted in three phases:
1. In vitro genotoxicity: Ames test (bacterial mutagenicity) and chromosomal aberration assay (mammalian cell clastogenicity).
2. Chronic oral toxicity: 6-month repeated-dose study in 60 Sprague-Dawley rats (10 males and 10 females per group across 3 doses).
3. Developmental toxicity: Prenatal study in 20–25 pregnant rats per group, dosed from gestation day 6–17.
Dosage & Administration
- In vitro: 5000 μg CFE/plate (Ames) and 5000 μg/mL (chromosomal aberration test).
- Chronic toxicity: Oral gavage at 100, 300, or 1000 mg/kg body weight/day.
- Developmental toxicity: Oral gavage at 250, 500, or 1000 mg/kg body weight/day.
Administration duration: 6 months for chronic toxicity; gestation days 6–17 for developmental toxicity.
Results & Efficacy
- Genotoxicity: No mutagenic effects in the Ames test (p>0.05 vs. control). Chromosomal aberration test showed no clastogenicity at 5000 μg/mL (p>0.05).
- Chronic toxicity: No mortality or clinical signs of toxicity observed at 100–1000 mg/kg. Body weight, food consumption, hematology, and organ histopathology remained normal. NOAEL: 1000 mg/kg/day.
- Developmental toxicity: No treatment-related maternal toxicity (e.g., weight gain, clinical signs) or fetal abnormalities (external, visceral, skeletal) at 250–1000 mg/kg. No dose-dependent trends in resorptions or litter size (p>0.05).
Limitations
- Species extrapolation: Findings in rats may not fully translate to humans.
- Short-term focus: Chronic toxicity tested over 6 months; longer-term effects unknown.
- Lack of mechanistic data: Study did not explore CFE’s pharmacological activity or metabolic pathways.
- Single formulation: Results apply only to the hydroethanolic extract tested, not other CFE preparations.
- No human trials: Safety in humans remains unconfirmed, requiring further clinical validation.
Clinical Relevance
This study supports the safety of Caralluma fimbriata hydroethanolic extract at doses up to 1000 mg/kg/day in rats, suggesting low risk for appetite-suppressing supplements using similar formulations. However, human trials are necessary to confirm these findings. Supplement users should note that while preclinical data are reassuring, individual variability and interactions with other substances remain unstudied. The absence of developmental toxicity in rats may be relevant for reproductive safety, but cross-species comparisons are speculative.
Source: PubMed (2013)
Original Study Reference
Safety assessment of a hydroethanolic extract of Caralluma fimbriata.
Source: PubMed
Published: 2013-01-01
📄 Read Full Study (PMID: 23771637)
