Table 4.

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

Nutritional Ingredient	Reference	Population (n)	Characteristics	Study Design	Duration	Intervention	Control/Comparator	Outcome Measured	Results
Fenugreek	DiSilvestro et al., 2011 [14]	n = 45	Age 43 ± 8; 24 females and 21 males; subjects experiencing heartburn after 3–8 meals per week for at least a month	RCT; placebo CG and IG were blinded, ranitidine positive CG group was unblinded; rescue medication tablets of chewable calcium carbonate were allowed	2 weeks	IG: 2000 mg 2x/day fenugreek capsules (4 g daily dose)	Placebo CG: starch capsules, four capsules taken twice/day; Positive CG: Ranitidine (Zantac 75), 75 mg, 2x/day, (150 mg daily dose)	Heartburn	The severity and incidence of heartburn significantly decreased with both the IG and the positive CG for both the first and second intervention week. The placebo also yielded significant effects for the second but not the first intervention week. All three interventions yielded statistically significant reductions in rescue medication use.
Galactomannan	Abenevoli et al., 2021 [15]	n = 60	Age ≥18; 47 males and 13 females; adults with GERD symptoms not taking PPIs	Single-center, RCT	2 weeks	IG: 10 mL, 3x/day liquid blend (calcium carbonate, sodium bicarbonate, Malva sylvestris, hyaluronic acid) (30 mL total)	CG: Placebo, one sachet containing 10 mL liquid, three times per day (30 mL total)	GERD	100% of patients reported at least 30% reduction in symptoms from baseline to week 3 of the trial (p < 0.001) as compared to placebo group. Symptom frequency and intensity were progressively significantly reduced from baseline to visit 4 (p < 0.001) in the IG as compared to placebo. Heartburn significantly decreased from baseline to day 14 for the IG (p < 0.001) versus an increase in score in CG (p > 0.05). There was a significant decrease in GERD symptoms from visit 2 to 3 to 4 (p < 0.001, p < 0.001, and p = 0.001 respectively) as compared to the CG.

IG = intervention group, CG = control group, RCT = randomized control trial.