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Effects of butyrate compared to donor faeces transplantation on metabolism and satiety in patients with metabolic syndrome

Effects of butyrate compared to donor faeces transplantation on metabolism and satiety in patients with metabolic syndrome - APPETITE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41779
Enrollment
36
Registered
2014-05-06
Start date
2014-12-22
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

gut microbiota metabolic syndrome

Interventions

Male or female postmenopausal metabolic syndrome patients will be randomised to receive either (N=12) autologous faecal transplantation followed by 4 grams of oral butyrate tablets once daily for 4

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Caucasian male or postmenopausal female - 50-70 years old - BMI *30 kg/m2 - At least 3 out of 5 NCEP metabolic syndrome criteria: fasting plasma glucose * 5.6 mmol/l, triglycerides * 1.7 mmol/l, waist-circumference > 102 cm (m) / > 88 cm (f), HDL-cholesterol * 1.04 mmol/l (m) / * 1.30 mmol/l (f), blood pressure * 130/85 mmHg

Exclusion criteria

Exclusion criteria: - Medication use, including PPI and antibiotics in last 3 months - Smoking, XTC, amphetamine or cocaine abuse - Alcohol abuse (>3/day) - Participation in a research protocol involving radiation exposure in the last 2 years. - eGFR

Design outcomes

Primary

MeasureTime frame
Differences in insulin sensitivity and lipolysis (including lipid content in muscle biopsies), as measured by a hyperinsulinemic euglycemic clamp and satiety as measured by validated eating behaviour questionnaires in combination with cerebral binding of the radioligand [123I]FP-CIT to serotonin transporters (as visualised by SPECT-scan) related to small intestinal serotonin levels in small intestinal biopsies.

Secondary

MeasureTime frame
Changes in faecal and small intestinal microbiota composition in relation to faecal energy excretion (24h faeces), resting and physical activity (accelerometers) intestinal permeability (faecal calprotectin levels), intestinal passage time (Sitzmark capsules), sympathetic tone (Nexfin) and plasma markers of low grade inflammation (LPS), glucose and lipid metabolism (proteomics), liver fat (MRI).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)