Diet ModificationNCT03829189
High-fiber Diet on the Body and the Brain
A study testing inulin and maltodextrin in people with Diet Modification and Overweight, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification, Overweight
- What is being tested?
- inulin and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jan 2019to 24 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body-mass-index 25-30kg/m^2
- females on contraception only
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Saxony, 04103
About this study
Official title: Interventional Study Comparing the Effect of a High-fiber Supplement Versus Placebo on the Body and the Brain
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
- Being tested
- inulin, maltodextrin
- Keywords
- microbiome, food wanting, memory, fiber
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inulinDietary supplement
prebiotic supplement
maltodextrinDietary supplement
placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| inulin | Active comparator | Not described Receives: Dietary Supplement: inulin |
| maltodextrin | Placebo comparator | Not described Receives: Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI BOLD activity during food wanting
Measured: 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.
Measured: 14 days
Secondary outcomes (14)
fMRI BOLD activity memory performance
Measured: 14 days
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
Measured: 14 days
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?"
Measured: 14 days
emotional health
BDI-II (Beck Depression Inventory); score minimum 0 to maximum 21
Measured: 14 days
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
Measured: 14 days
satiety
self-reported hunger scale; visual analogue scale; score minimum 0 to maximum 8
Measured: 14 days
serum lipid metabolism markers
total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
Measured: 14 days
serum glucose metabolism markers
glucose, insulin
Measured: 14 days
serum glucose metabolism markers
long-term glucose marker HbA1C
Measured: 14 days
serum inflammatory markers
high sensitivity C-reactive protein, interleukin-6
Measured: 14 days
hunger hormones
leptin, ghrelin, Glucagon-like peptide-1 (GLP-1), peptide YY
Measured: 14 days
serum microbial metabolic markers
short-chain fatty acids (SCFA), trimethylamine N-oxide (TMAO), bile acids
Measured: 14 days
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
Measured: 14 days
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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start14 Jan 2019
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829189
- Sponsor's protocol ID
- GUT_BRAIN
- Status last verified
- Nov 2020
- First submitted
- 11 Jan 2019
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37793780Medawar 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.
PubMed 34599144
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study Comparing the Effect of a High-fiber Supplement Versus Placebo on the Body and the Brain
- ClinicalTrials.gov ID
- NCT03829189
- Acronym / sponsor ID
- GUT_BRAIN
- Conditions
- Diet Modification, Overweight
- Keywords
- microbiome, food wanting, memory, fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain SciencesUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| inulin | Active comparator | Dietary Supplement: inulin |
| maltodextrin | Placebo comparator | Dietary Supplement: maltodextrin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- body-mass-index 25-30kg/m^2
- females on contraception only
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inulinprebiotic supplement | Dietary supplement | inulin |
| maltodextrinplacebo supplement | Dietary supplement | maltodextrin |
Primary outcome
fMRI BOLD activity during food wanting
Time frame: 14 days
microbial alpha and beta diversity
Time frame: 14 days
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 secondary outcomes
fMRI BOLD activity memory performance
Time frame: 14 days
positive and negative affect
Time frame: 14 days
mood
Time frame: 14 days
emotional health
Time frame: 14 days
well-being
Time frame: 14 days
satiety
Time frame: 14 days
serum lipid metabolism markers
Time frame: 14 days
serum glucose metabolism markers
Time frame: 14 days
serum glucose metabolism markers
Time frame: 14 days
serum inflammatory markers
Time frame: 14 days
hunger hormones
Time frame: 14 days
serum microbial metabolic markers
Time frame: 14 days
personality traits
Time frame: 14 days
gastrointestinal health
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Derived from this study: PubMed 37793780Medawar 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.
- Derived from this study: PubMed 34599144Medawar 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.
Related trials for Diet Modification
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inulin and maltodextrin in people with Diet Modification and Overweight, run by Max Planck Institute for Human Cognitive and Brain Sciences at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI BOLD activity during food wanting (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03829189, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.