High-fiber Diet on the Body and the Brain
- Conditions
- OverweightDiet Modification
- Interventions
- Dietary Supplement: maltodextrinDietary Supplement: inulin
- Registration Number
- NCT03829189
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- body-mass-index 25-30kg/m^2
- females on contraception only
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description maltodextrin maltodextrin - inulin inulin -
- Primary Outcome Measures
Name Time Method fMRI BOLD activity during food wanting 14 days microbial alpha and beta diversity 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
Name Time Method positive and negative affect 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
mood 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?"
emotional health 14 days BDI-II (Beck Depression Inventory); score minimum 0 to maximum 21
satiety 14 days self-reported hunger scale; visual analogue scale; score minimum 0 to maximum 8
hunger hormones 14 days leptin, ghrelin, Glucagon-like peptide-1 (GLP-1), peptide YY
fMRI BOLD activity memory performance 14 days well-being 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
serum lipid metabolism markers 14 days total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
serum glucose metabolism markers 14 days long-term glucose marker HbA1C
serum inflammatory markers 14 days high sensitivity C-reactive protein, interleukin-6
personality traits 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
serum microbial metabolic markers 14 days short-chain fatty acids (SCFA), trimethylamine N-oxide (TMAO), bile acids
gastrointestinal health 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
Trial Locations
- Locations (1)
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
🇩🇪Leipzig, Saxonia, Germany