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A comparative study of the role of intestinal acetate production in human appetite and insulin secretion and insulin sensitivity

A comparative study of the role of intestinal acetate production in human appetite and insulin secretion and insulin sensitivity

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28226
Enrollment
54
Registered
2018-07-09
Start date
2018-07-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We will include subjects from the Amsterdam HELIUS study (n=6000) and include only those with 10% lowest and 10% highest fecal butyryl-coenzyme A transferase enzyme (based on previously obtained results of 16S analysis and cross-validated by qPCR butyryl CoA transferase) will be approached for this study.

Interventions

(high fiber) containing standardized mixed meal test

Sponsors

AMC-UvA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Male or female - Stable bodyweight (<5% reported weight change during the previous 3 months) - Age 18-65 years - Caucasian (i.e.: Dutch or Turkish nationality) - Able and willing to give informed consent

Exclusion criteria

Exclusion criteria: - Use of corticosteroids, antibiotics and other immunomodulating medication in last 3 months - XTC, amphetamine, nicotine or cocaine abuse, based on the 20 item drug abuse screening test (DAST-20) - Alcohol abuse (> 3 units per day) - Contraindication for MRI (neurological illness , malignancy, history of major heart disease, history of major renal disease, pregnancy or breast feeding, pacemaker and metals contraindicated for MRI present in the body) - Expected prolonged compromised immunity (due to recent cytotoxic chemotherapy or - HIV infection with a CD4 count <240) - Presence of inflammatory bowel disease (IBD)2 - Inability to understand the study protocol, give informed consent or participate adequately in study protocol

Design outcomes

Primary

MeasureTime frame
- differences in Postprandial plasma acetate levels after a SMMT - differences in Baseline Intestinal microbiota composition (morning stool samples) - differences in baseline Faecal acetate levels

Secondary

MeasureTime frame
- CNS (fMRI) responses to food pictures (BOLD) signal, i.e. in CNS activation in predefined regions (insula, striatum, amygdala, OFC, PFC, hippocampus and hypothalamus) in response to viewing food pictures or consuming actual food - Insulin sensitivity measured as Matsuda’s insulin sensitivity index during the standardized mixed meal test - Insuline secretion measured as c-peptide response during the standardized mixed meal test - Energy metabolism, measured by resting energy expenditure (REE) - Baseline physical activity energy expenditure (PAEE) - Dietary intake (https://mijn.voedingscentrum.nl/nl/eetmeter), weight and body composition (Body Impedance Analysis, BIA). - Subjective appetite sensations and eating behavior (VAS questionnaires)

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)