High-fiber Diet on the Body and the Brain

Overweight Clinical Trial

Official title:

Interventional Study Comparing the Effect of a High-fiber Supplement Versus Placebo on the Body and the Brain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829189
• Other study ID #: GUT_BRAIN
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: November 24, 2020

Study information

• Verified date: November 2020
• Source: Max Planck Institute for Human Cognitive and Brain Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 24, 2020
• Est. primary completion date: November 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification
• Overweight

Intervention

Dietary Supplement:
• inulin
prebiotic supplement
• maltodextrin
placebo supplement

Locations

Country	Name	City	State
Germany	Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences	Leipzig	Saxonia

Sponsors (1)

Lead Sponsor	Collaborator
Max Planck Institute for Human Cognitive and Brain Sciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI BOLD activity during food wanting		14 days
Primary	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	fMRI BOLD activity memory performance		14 days
Secondary	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	14 days
Secondary	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?"	14 days
Secondary	emotional health	BDI-II (Beck Depression Inventory); score minimum 0 to maximum 21	14 days
Secondary	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	14 days
Secondary	satiety	self-reported hunger scale; visual analogue scale; score minimum 0 to maximum 8	14 days
Secondary	serum lipid metabolism markers	total cholesterol, triglycerides, high density lipoprotein, low density lipoprotein	14 days
Secondary	serum glucose metabolism markers	glucose, insulin	14 days
Secondary	serum glucose metabolism markers	long-term glucose marker HbA1C	14 days
Secondary	serum inflammatory markers	high sensitivity C-reactive protein, interleukin-6	14 days
Secondary	hunger hormones	leptin, ghrelin, Glucagon-like peptide-1 (GLP-1), peptide YY	14 days
Secondary	serum microbial metabolic markers	short-chain fatty acids (SCFA), trimethylamine N-oxide (TMAO), bile acids	14 days
Secondary	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	14 days
Secondary	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	14 days