Table 7.

Summary of human trials on non-botanical ingredients and upper GI conditions.

Nutritional Ingredient	Reference	Population (n)	Characteristics	Study Design	Duration	Intervention	Control/Comparator	Outcome Measured	Results
Activated Charcoal (AC)	Coffin et al., 2011 [80]	n = 276	Age: 18–49; mean age 39 ± 10 years; 70% female; functional dyspeptic patients per ROME III criteria	RCT, phase III trial	30 days	IG: 2 capsules 3x per day of AC formula (gastro-soluble capsule containing 140mg of AC, 45mg of simethicone INN, and 180mg of magnesium oxide, plus enteric coated capsule containing 140mg of AC and 45mg of simethicone INN)	CG: 2 placebo capsules, 3x per day	Functional dyspepsia	IG saw significantly greater absolute and relative symptom reductions compared to placebo. The IG observed a significant reduction in post-prandial fullness (p = 0.034), epigastric pain (p = 0.045), epigastric burning (p = 0.03), and bloating (p = 0.03), in comparison to placebo, and early satiety approached significance (p = 0.051).
Activated Charcoal	Lecuyer et al., 2009 [81]	n = 132	Age: 18–49; mean age: 39.0±8.8 years; functional dyspepsia patients	RCT	3 months and 2-month follow-up period	IG: 2 capsules, 3x per day AC formula during meals (gastro-soluble and enteric capsules containing 140 mg AC and 45 mg simethicone)	CG: 2 capsules placebo, 3x per day during meals	Functional dyspepsia	Greater percentage of patients with a reduction of at least two points on the symptoms intensity scale in IG compared to CG (p = 0.043) although there was a nonsignificant difference between the two groups regarding overall patient complaints (p = 0.115). IG also saw greater reduction in intensity of abdominal fullness, bloating, and the sensation of slow digestion versus placebo (p < 0.05).
Zinc-l-Carnosine (polaprezinc) (ZnC)	Tan et al., 2017 [82]	n = 303	Age: 18–70; 168 females and 164 males; patients with H. pylori-associated gastritis	RCT	2 weeks	IG: Arm A: triple therapy (omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily) plus polaprezinc 75 mg, twice daily (150 mg total); Arm B: triple therapy plus polaprezinc 150 mg, twice daily (300 mg total)	CG: Arm C triple therapy alone	H. pylori associated gastritis	All three arms saw significant gastrointestinal symptom improvement, including abdominal pain, acid reflux, belching, heartburn, bloating, nausea, and vomiting at days 7, 14, and 28 when compared to baseline (p < 0.0001) with no significant difference between groups. Both the intention to treat (ITT) and per-protocol (PP) analyses showed that Arms A and B had a significantly higher rate of H. pylori eradication than Arm C while there was no significant difference between the rate of eradication in Arms A and B.

AC: Activated charcoal, ZnC: zinc-l-carnosine.