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Table 2 Adverse events reported in human studies

From: Evaluation of adverse effects/events of genetically modified food consumption: a systematic review of animal and human studies

Study ID

Study design

Participant

Sample size (male/female)

Intervention

Dosage

Duration

Generation

Adverse event

West AL 2019 [97]

Double-blind crossover trial

Male younger participants

(18 to 30 years)

10

450 mg eicosapentaenoic plus decosahexaenoic from either 455 mg transgenic Camelina sativa seed oil (CSO) or 452 mg commercial blended fish oil (BFO) in test meal (a milkshake drink, and toast and jam)

455 mg CSO or 452 mg BFO in the test meal

2 single breakfast with at least 14 days apart

1

No specific oil-related minor illness and no test oil-related consequences. No major adverse symptoms or health effects. The minor illness was as follows:

1. 2 cases of minor upper respiratory tract infections (a cold and tonsillitis) out of the seventy-two postprandial sessions* (2 sessions for each of the 36 participants)

2. 1 case of minor nose bleed some hours after one postprandial session with a pre-existing non-clinical tendency towards this

3. 1 case of pyelonephritis between postprandial sessions which was fully resolved

4. 3 cases of headaches during both postprandial sessions

  

Female younger participants

(18 to 30 years)

10

  

Male older participants

(50 to 65 years)

6

   
  

Male older participants

(50 to 65 years)

10

   
  1. *Postprandial session means 8 h after each meal, during which venous blood samples were collected