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Randomized Controlled Trial
. 2023 Jun 15;15(12):2752.
doi: 10.3390/nu15122752.

Oligomalt, a New Slowly Digestible Carbohydrate, Is Well Tolerated in Healthy Young Men and Women at Intakes Up to 180 Gram per Day: A Randomized, Double-Blind, Crossover Trial

Odd Erik Johansen  1 , Delphine Curti  2 , Maximilian von Eynatten  1 , Andreas Rytz  3 , Anirban Lahiry  3 , Frederik Delodder  3 , Gerhard Ufheil  4   5 , Carmine D'Urzo  1 , Audrey Orengo  2 , Kate Thorne  1 , Jaclyn S Lerea-Antes  5   6
Affiliations
Randomized Controlled Trial

Oligomalt, a New Slowly Digestible Carbohydrate, Is Well Tolerated in Healthy Young Men and Women at Intakes Up to 180 Gram per Day: A Randomized, Double-Blind, Crossover Trial

Odd Erik Johansen et al. Nutrients. .

Abstract

In this randomized, double-blind triple-crossover study (NCT05142137), the digestive tolerance and safety of a novel, slowly digestible carbohydrate (SDC), oligomalt, an α-1,3/α-1,6-glucan α-glucose-based polymer, was assessed in healthy adults over three separate 7-day periods, comparing a high dose of oligomalt (180 g/day) or a moderate dose of oligomalt (80 g/day in combination with 100 g maltodextrin/day) with maltodextrin (180 g/day), provided as four daily servings in 300 mL of water with a meal. Each period was followed by a one-week washout. A total of 24 subjects (15 females, age 34 years, BMI 22.2 kg/m2, fasting blood glucose 4.9 mmol/L) were recruited, of whom 22 completed the course. The effects on the primary endpoint (the Gastrointestinal Symptom Rating Score (GSRS)) showed a statistically significant dose dependency, albeit of limited clinical relevance, between a high dose of oligomalt and maltodextrin (mean (95% CI) 2.29 [2.04, 2.54] vs. 1.59 [1.34, 1.83], respectively; difference: [-1.01, -0.4], p < 0.0001), driven by the GSRS-subdomains "Indigestion" and "Abdominal pain". The GSRS difference ameliorated with product exposure, and the GSRS in those who received high-dose oligomalt as their third intervention period was similar to pre-intervention (mean ± standard deviation: 1.6 ± 0.4 and 1.4 ± 0.3, respectively). Oligomalt did not have a clinically meaningful impact on the Bristol Stool Scale, and it did not cause serious adverse events. These results support the use of oligomalt across various doses as an SDC in healthy, normal weight, young adults.

Keywords: clinical trial; dietary carbohydrate; food; gastrointestinal tolerance.

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Conflict of interest statement

Odd Erik Johansen, Maximilian von Eynatten, Carmine D’Urzo, and Kate Thorne are employed by Nestlé Health Science, Lausanne, Switzerland. Delphine Curti, Andreas Rytz, Anirban Lahiry, Frederik Delodder, and Audrey Orengo are employed by Nestlé Research, Lausanne, Switzerland. Gerhard Ufheil is employed by Nestlé Research and Development, Konolfingen, Switzerland. Jaclyn S. Lerea-Antes is employed by Nestlé Health Science, Bridgewater, United Sates.

Figures

Figure 1
Figure 1
Effect on total score for Gastrointestinal Symptom Rating Scale by intervention, regardless of intervention sequence. The figure shows the mean (95% CI) (Y-axis), and the differences between different interventions are expressed with 95% CI and p-values. Abbreviations: g—day; CI—confidence interval.
Figure 2
Figure 2
Subdomain scores for the Gastrointestinal Symptom Rating Scale (GSRS) by intervention, regardless of intervention sequence. The figure shows the mean (95% CI) (Y-axis) as well as the published GSRS subdomain normative scores. Abbreviations: g—day; CI—confidence interval.
Figure 3
Figure 3
Total score for Gastrointestinal Symptom Rating Scale by period regardless of intervention. The figure shows the mean (95% CI) (Y-axis), and the differences between different periods are expressed with 95% CI and p-values. Abbreviations: CI—confidence interval.
Figure 4
Figure 4
Total Gastrointestinal Symptom Rating Scale by intervention and intervention period. The figure shows the mean Gastrointestinal Symptom Rating Scale (SD) (Y-axis) over the three treatment periods by intervention and published normative score. Baseline denotes score at V1. Abbreviations: g—day; SD—standard deviation.
Figure 5
Figure 5
Bristol Stool Scale by intervention in the overall population (FAS). The figure shows the mean (95% CI) (Y-axis) as well as the published Bristol Stool Scale normative scores. Abbreviations: g—day; CI—confidence interval.
Figure 6
Figure 6
Stool frequency by intervention and period. The figure shows mean stool frequency (SD) (Y-axis) over the three treatment periods by intervention. Abbreviations: g—day; SD—standard deviation.
See this image and copyright information in PMC

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