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Trial record 80 of 562 for:    maltodextrin

High-fiber Diet on the Body and the Brain

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ClinicalTrials.gov Identifier: NCT03829189
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Max Planck Institute for Human Cognitive and Brain Sciences

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.

Condition or disease Intervention/treatment Phase
Diet Modification Overweight Dietary Supplement: inulin Dietary Supplement: maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Interventional Study Comparing the Effect of a High-fiber Supplement Versus Placebo on the Body and the Brain
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Inulin

Arm Intervention/treatment
Active Comparator: inulin Dietary Supplement: inulin
prebiotic supplement

Placebo Comparator: maltodextrin Dietary Supplement: maltodextrin
placebo supplement




Primary Outcome Measures :
  1. fMRI BOLD activity during food wanting [ Time Frame: 14 days ]
  2. 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.


Secondary Outcome Measures :
  1. fMRI BOLD activity memory performance [ Time Frame: 14 days ]
  2. positive and negative affect [ Time Frame: 14 days ]
    PANAS (Positive and Negative Affect Schedule); scores can range from 10 - 50, with higher (lower) scores representing higher (lower) levels of positive (negative) affect

  3. mood [ Time Frame: 14 days ]
    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?"

  4. emotional health [ Time Frame: 14 days ]
    BDI-II (Beck Depression Inventory); score minimum 0 to maximum 21

  5. well-being [ Time Frame: 14 days ]
    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

  6. satiety [ Time Frame: 14 days ]
    self-reported hunger scale; visual analogue scale; score minimum 0 to maximum 8

  7. serum lipid metabolism markers [ Time Frame: 14 days ]
    total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein

  8. serum glucose metabolism markers [ Time Frame: 14 days ]
    glucose, insulin

  9. serum glucose metabolism markers [ Time Frame: 14 days ]
    long-term glucose marker HbA1C

  10. serum inflammatory markers [ Time Frame: 14 days ]
    high sensitivity C-reactive protein, interleukin-6

  11. hunger hormones [ Time Frame: 14 days ]
    leptin, ghrelin, Glucagon-like peptide-1 (GLP-1), peptide YY

  12. serum microbial metabolic markers [ Time Frame: 14 days ]
    short-chain fatty acids (SCFA), trimethylamine N-oxide (TMAO), bile acids

  13. personality traits [ Time Frame: 14 days ]
    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

  14. gastrointestinal health [ Time Frame: 14 days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829189


Contacts
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Contact: Veronica Witte, PhD +49 341 9940 24 26 witte@cbs.mpg.de
Contact: Evelyn Medawar, Dual MSc +49 341 9940 2407 medawar@cbs.mpg.de

Locations
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Germany
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences Recruiting
Leipzig, Saxonia, Germany, 04103
Contact: Evelyn Medawar, Dual MSc    +49 341 9940 2407    medawar@cbs.mpg.de   
Contact: Veronica Witte, PhD       witte@cbs.mpg.de   
Principal Investigator: Veronica Witte, PhD         
Sponsors and Collaborators
Max Planck Institute for Human Cognitive and Brain Sciences

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Responsible Party: Max Planck Institute for Human Cognitive and Brain Sciences
ClinicalTrials.gov Identifier: NCT03829189     History of Changes
Other Study ID Numbers: GUT_BRAIN
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Max Planck Institute for Human Cognitive and Brain Sciences:
microbiome
food wanting
memory
fiber
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms