High-fiber Diet on the Body and the Brain

NCT03829189 | Completed

• 1 other identifier: GUT_BRAIN
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The central research question aims to understand what drives individuals to make and maintain a vegan / vegetarian dietary decision, to investigate whether there are possible predictors that might influence such a decision and whether personality differences already exist or can only be measured after the change in diet. The investigators will examine the effects of a high-fiber diet on food wanting on a neural and on a behavioral level. The microbiome is suggested to mediate the expected changes in food wanting.

Conditions

Diet Modification; Overweight

Keywords

microbiome; food wanting; memory; fiber

Outcome Measures

Primary Outcomes (2)

• fMRI BOLD activity during food wanting

  14 days

• microbial alpha and beta diversity

  The taxonomic structure of the microbial community will be determined using 16S rRNA gene sequencing. The reads from the sequencing data will be assigned to taxa by sequence similarity using puplic available data bases. Relative distribution of microbial taxa is then based on the number of reads assigned to each taxa. For the description of the the community the alpha diversity of each sample will be determined based on species richness, evenness of species distribution which is combined in the single value of the Shannon diversity index. Furthermore beta-diversity, how the microbial communities differ between sample, will be analysed by principal component analysis as well as non-metric multidimensional scaling. In addition, for each taxa significant difference between sample groups will be assessed by comparing the relative number of reads.

  14 days

Secondary Outcomes (14)

• fMRI BOLD activity memory performance

  14 days

• positive and negative affect

  14 days

• mood

  14 days

• emotional health

  14 days

• well-being

  14 days

Study Arms (2)

inulin

ACTIVE COMPARATOR

Dietary Supplement: inulin

maltodextrin

PLACEBO COMPARATOR

Dietary Supplement: maltodextrin

Interventions

inulin DIETARY_SUPPLEMENT

prebiotic supplement

inulin

maltodextrin DIETARY_SUPPLEMENT

placebo supplement

maltodextrin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body-mass-index 25-30kg/m\^2
• females on contraception only

You may not qualify if:

• current neurological or psychiatric illness
• daily consumption of more than 50 g of alcohol, more than 10 cigarettes or more than 6 cups of coffee
• use of antidepressants or other centrally acting drugs
• type 2 diabetes mellitus or other serious metabolic disorders
• MRI contraindication (e.g. cardiac pacemaker, drug pump, shunts)
• major untreated medical condition, including gastrointestinal organs, lungs, heart, cardiovascular system, liver and kidney)
• diet-related restrictions (food allergies, food intolerances, known nutrient deficiencies or a recent history of dieting or restrictive eating behaviour, including vegan, vegetarian diet)
• current pregnancy or lactation

Sponsors & Collaborators

• Max Planck Institute for Human Cognitive and Brain Sciences: lead

Study Sites (1)

Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, Saxony, 04103, Germany

Location

Related Publications (2)

• Medawar E, Beyer F, Thieleking R, Haange SB, Rolle-Kampczyk U, Reinicke M, Chakaroun R, von Bergen M, Stumvoll M, Villringer A, Witte AV. Prebiotic diet changes neural correlates of food decision-making in overweight adults: a randomised controlled within-subject cross-over trial. Gut. 2024 Jan 5;73(2):298-310. doi: 10.1136/gutjnl-2023-330365.

  PMID: 37793780 DERIVED

• Medawar E, Haange SB, Rolle-Kampczyk U, Engelmann B, Dietrich A, Thieleking R, Wiegank C, Fries C, Horstmann A, Villringer A, von Bergen M, Fenske W, Veronica Witte A. Gut microbiota link dietary fiber intake and short-chain fatty acid metabolism with eating behavior. Transl Psychiatry. 2021 Oct 1;11(1):500. doi: 10.1038/s41398-021-01620-3.

  PMID: 34599144 DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Inulin; maltodextrin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: inulin; minimum of 14 days wash-out; 14 days placebo Arm 2: 14 days placebo; minimum of 14 days wash-out; 14 days placebo

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: February 4, 2019
• Study Start: January 14, 2019
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

DE (1)