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Effect of sugar beet pectin on bowel habit and gut microbiota in healthy adults with hard stools: a randomized, double-blind, placebo controlled trial

Effect of sugar beet pectin on bowel habit and gut microbiota in healthy adults with hard stools: a randomized, double-blind, placebo controlled trial - UltraPulp

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030572
Enrollment
40
Registered
2023-01-06
Start date
2022-11-07
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hard stools, tendency to constipation

Interventions

Group 1: Intervention: sugar beet pectin, 15g/day p.o. (3 x 5 capsules a 1 g), for 28 days Group 2: Placebo: Maltodextrin 9/day p.o. (3 x 5 capsules, a 0.6 g), for 28 days Due to the lower bulk densit

Sponsors

Cosun Beet Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Healthy subjects - Hard stools defined by Bristol Stool Form Scale (category 1 to =2) - Omnivore diet - Age: 18 - 80 years - All genders - BMI (kg/m²): 18,5 - 34.9 - non-Smoker

Exclusion criteria

Exclusion criteria: - Subjects with stool consistency =3 (Bristol Stool Form Scale) - Presence of acute/ chronic diseases - Clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility, such as: coeliac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease diagnosed according to Rome III criteria with diarrhea-predominant type, irritable bowel syndrome diagnosed according to Rome IV criteria (highest level according to IBS-SSS), relevant bowel resections including short bowel syndrome - Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial - Regular intake of prebiotics or products claimed as “prebiotic”, “probiotic”, dietary fibres supplements and laxatives (medicinal drugs to promote intestinal transit) during the study - Vegan, vegetarian diet - Strongly atypical or restrictive diets/concepts followed voluntarily (macrobiotics, paleo diet, Atkins diet, Mayo diet, Insticto diet) or due to food intolerances/food allergies - Average daily alcohol consumption > 10 g for women and > 20 g for men, consideration of alcohol abuse - Athletes (extensive physical activity) - Current use of antibiotics - Willingness to discontinue laxatives approved as medicines - Simultaneous participation in other studies that are associated with drug use and have a potentially significant impact on body composition or dietary behaviour - Lactation, pregnancy, planned pregnancies that interfere with the study period

Design outcomes

Primary

MeasureTime frame
- Bristol Stool Form Scale (BSFS)

Secondary

MeasureTime frame
- Number of bowel movements - PAC-SYM (constipation-related symptom questionnaire, Likert-scale 0-4) - PAC-QoL (constipation constipation-related quality of life questionnaire, Likert-scale 1-5) - Gut microbiota composition

Countries

Germany

Contacts

Public ContactSusanne Esau

Hochschule Neubrandenburg – University of Applied Sciences, Institut für evidenz-basierte Diätetik (NIED)

esau@hs-nb.de+49 395 56932521

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026