Effects of Changing Intestinal Transit Time on Gut Microbial Composition and Metabolism

University of Copenhagen22 enrolled

Overview

The aim of this study is to investigate how a short versus a long transit time impacts the gut microbiome's response to a high-fiber and a low-fiber diet, respectively. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.

The study consists of two parallel arms of whole-meal diets, a low-fiber diet, and a high-fiber diet, respectively. Each arm is designed as a cross-over where participants, in random order, are administered a laxative (Movicol) along with the provided diet to shorten their intestinal transit time or simply consume the provided whole-meal diet (control). The two intervention periods both involve the following: * One week of run-in where participants consume the provided whole-meal diet. * One week where participants either consume Movicol with the provided whole-meal diet or simply continue consuming the provided whole-meal diet (control). Both arms begin with a screening visit and one week where participants consume and record their habitual diets. Subsequently, the first intervention period follows with one visit before and after each of the two weeks (visit 1-3) followed by the second intervention period with one visit before and after each of the two weeks (visit 4-6). The two cross-over periods are split by a washout of at least two weeks. The study thus runs for approximately 7-8 weeks depending on the length of the washout and consists of seven visits (one screening visit and six regular visits) in total.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diet, Healthy Metabolic Disease

Interventions

Diet + laxativeDRUG

The participants will start by consuming one sacket of Movicol powder (13 g macrogol 3350) on the first day. On day 2, the participants will consume two sackets of Movicol powder (26 g macrogol 3350), one with breakfast in the morning and one before sleep in the evening. The participants will continue consuming two sackets per day (one morning, one evening) until the following study visit, day 8 (seven days in total). If the participants have a very loose stomach (recorded as Bristol stool scale ≥6), they will be instructed to reduce Movicol by one sacket/day. In case the participants have not passed a stool on day 2 or in the morning of day 3, the participants will increase the dose to a maximum of three sackets of Movicol powder (39 g macrogol 3350) per day (morning, noon, and evening) and continue this until the following study visit at day 8. If three sackets cause very loose stomach the participants will decrease the number of sackets consumed.

Diet onlyOTHER

This is only a control and participants will not receive Movicol.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18.5-30.0 kg/m2 BMI * Self-reported ≤3.5 spontaneous bowel movements per week * Willing to collect urine and stool samples at home and able to temporarily store them in their own freezer in a provided container. * Willing to eat the foods provided. * Owns a smartphone (iOS 11.0 and later or Android 5.0 and up) with access to the internet. Exclusion Criteria: * Pregnant or lactating women. * Diagnosis of irritable bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO), inflammatory bowel diseases (IBD), Gastrointestinal obstruction, or Ischemic colitis * Diagnosed constipation according to the ROME IV criteria * Intake of antibiotics ˂ 1month, or any medication that can affect the outcomes of the study * Regular use of diarrhea inhibitors or laxatives * Dysphagia * Any chronic disease that can affect the outcomes of the study or pose a risk when consuming Movicol * Intake of medications potentially altering gastric pH (proton pump inhibitors, histamine receptor antagonists, antacids) * Intake of medications potentially altering the gastrointestinal motility (prokinetics, antiemetic agents, anti-cholinergic agents, narcotic analgetics, nonsteroidal anti-inflammatory drugs, and peroral glucocorticoids) * Concurrent participation in another trial * Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer´s participation

Locations (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, Denmark

Outcomes

Primary Outcomes

Fecal butyrate over urine p-cresol sulfate ratio

Changes in ratio between fecal butyrate (reflecting saccharolytic fermentation) and urine p-cresol sulfate (reflecting proteolytic fermentation) between interventions.