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High-fiber Diet on the Body and the Brain

Primary Purpose

Diet Modification, Overweight

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
inulin
maltodextrin
Sponsored by
Max Planck Institute for Human Cognitive and Brain Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diet Modification focused on measuring microbiome, food wanting, memory, fiber

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

inulin

maltodextrin

Arm Description

Outcomes

Primary Outcome Measures

fMRI BOLD activity during food wanting
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.

Secondary Outcome Measures

fMRI BOLD activity memory performance
positive and negative affect
PANAS (Positive and Negative Affect Schedule); scores can range from 10 - 50, with higher (lower) scores representing higher (lower) levels of positive (negative) affect
mood
POMS (Profile of Mood States); four scales (Depression/Anxiety, Fatigue, Vigor, Anger), 35 items, 7 point scale, instruction "How you have been feeling during the past 24 hours?"
emotional health
BDI-II (Beck Depression Inventory); score minimum 0 to maximum 21
well-being
WHO-5 (World Health Organization Well-Being Index); measures life quality and life contentment; score minimum 0 to maximum 5 with higher score representing higher life quality and life contentment
satiety
self-reported hunger scale; visual analogue scale; score minimum 0 to maximum 8
serum lipid metabolism markers
total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
serum glucose metabolism markers
glucose, insulin
serum glucose metabolism markers
long-term glucose marker HbA1C
serum inflammatory markers
high sensitivity C-reactive protein, interleukin-6
hunger hormones
leptin, ghrelin, Glucagon-like peptide-1 (GLP-1), peptide YY
serum microbial metabolic markers
short-chain fatty acids (SCFA), trimethylamine N-oxide (TMAO), bile acids
personality traits
BFMM (BIG FIVE Mine Marker); measures the Big Five personality traits as states; 5 subscales (neuroticism, extraversion, openness, agreeableness, conscientiousness); higher scores means being more extreme for a certain state
gastrointestinal health
GQLI-10 (Gastrointestinal Quality of Life Index); 10 items to measure quality of life regarding gastrointestinal symptoms; the higher the score the stronger the symptoms

Full Information

First Posted
January 11, 2019
Last Updated
November 25, 2020
Sponsor
Max Planck Institute for Human Cognitive and Brain Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03829189
Brief Title
High-fiber Diet on the Body and the Brain
Official Title
Interventional Study Comparing the Effect of a High-fiber Supplement Versus Placebo on the Body and the Brain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
November 24, 2020 (Actual)
Study Completion Date
November 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max Planck Institute for Human Cognitive and Brain Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Modification, Overweight
Keywords
microbiome, food wanting, memory, fiber

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inulin
Arm Type
Active Comparator
Arm Title
maltodextrin
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
inulin
Intervention Description
prebiotic supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Intervention Description
placebo supplement
Primary Outcome Measure Information:
Title
fMRI BOLD activity during food wanting
Time Frame
14 days
Title
microbial alpha and beta diversity
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
fMRI BOLD activity memory performance
Time Frame
14 days
Title
positive and negative affect
Description
PANAS (Positive and Negative Affect Schedule); scores can range from 10 - 50, with higher (lower) scores representing higher (lower) levels of positive (negative) affect
Time Frame
14 days
Title
mood
Description
POMS (Profile of Mood States); four scales (Depression/Anxiety, Fatigue, Vigor, Anger), 35 items, 7 point scale, instruction "How you have been feeling during the past 24 hours?"
Time Frame
14 days
Title
emotional health
Description
BDI-II (Beck Depression Inventory); score minimum 0 to maximum 21
Time Frame
14 days
Title
well-being
Description
WHO-5 (World Health Organization Well-Being Index); measures life quality and life contentment; score minimum 0 to maximum 5 with higher score representing higher life quality and life contentment
Time Frame
14 days
Title
satiety
Description
self-reported hunger scale; visual analogue scale; score minimum 0 to maximum 8
Time Frame
14 days
Title
serum lipid metabolism markers
Description
total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
Time Frame
14 days
Title
serum glucose metabolism markers
Description
glucose, insulin
Time Frame
14 days
Title
serum glucose metabolism markers
Description
long-term glucose marker HbA1C
Time Frame
14 days
Title
serum inflammatory markers
Description
high sensitivity C-reactive protein, interleukin-6
Time Frame
14 days
Title
hunger hormones
Description
leptin, ghrelin, Glucagon-like peptide-1 (GLP-1), peptide YY
Time Frame
14 days
Title
serum microbial metabolic markers
Description
short-chain fatty acids (SCFA), trimethylamine N-oxide (TMAO), bile acids
Time Frame
14 days
Title
personality traits
Description
BFMM (BIG FIVE Mine Marker); measures the Big Five personality traits as states; 5 subscales (neuroticism, extraversion, openness, agreeableness, conscientiousness); higher scores means being more extreme for a certain state
Time Frame
14 days
Title
gastrointestinal health
Description
GQLI-10 (Gastrointestinal Quality of Life Index); 10 items to measure quality of life regarding gastrointestinal symptoms; the higher the score the stronger the symptoms
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: body-mass-index 25-30kg/m^2 females on contraception only Exclusion Criteria: 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
Facility Information:
Facility Name
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
City
Leipzig
State/Province
Saxonia
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34599144
Citation
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.
Results Reference
derived

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High-fiber Diet on the Body and the Brain

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