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ID
Source
Brief title
Health condition
metabolic syndrome
insulin resistance
microbiota
mediterranean diet
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect of mediterranean diet followed by lean donor FMT versus mediterranean diet followed by autologous FMT on intestinal microbiota composition at 0,3,6, and 12 weeks .
Secondary outcome
changes in insulin sensitivity (hyperinsulinemic clamp) at baseline and after 6 weeks
Secundary objective:
- Changes in postprandial plasma glucose and incretins (mixed meal test) at baseline and 6 weeks
- Changes in subcutaneous adipose tissue inflammation (Subcutaneous adipose tissue biopsy) at baseline and 6 weeks
- Changes in 24h fecal and urine metabolites (feces and urine samples)
Background summary
Previous research has shown that faecal microbiota transplantation of lean healthy donors improves insulin sensitivity (Vrieze et al., 2012) and recent data have suggested that engraftment of beneficial lean donor bacterial differs between metabolic syndrome subjects (Li-Nieuwdorp, Science 2016). Since diet is thought to be of pivotal importance in stabilizing gutmicrobiota composition (David et al., 2014; De Filippis et al., 2015) we hypothesize that prescription of a healthy (Mediterranean) diet before lean donor fecal transplantation will allow enhanced engraftment of beneficial bacteria in the intestine of metabolic syndrome subject and will have a synergistic beneficial effect on peripheral insulin sensitivity.
Study objective
To study if a Mediterranean diet (MD) followed by lean donor fecal microbiota transplantation (FMT) has synergistic superior beneficial effects on peripheral insulin sensitivity and (small) intestinal microbiota composition as compared to prescription of Mediterranean diet (MD) followed by autologous (own) FMT in male subjects with metabolic syndrome.
Study design
0.6 weeks
Intervention
fecal transplantation (allogeneic/lean donor or autologous) on top of mediterranean diet
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Inclusion criteria
-Male obese subjects with metabolic syndrome
-21 to 65 years-old
-body mass index (BMI) 30 to 43 kg/m2)
-3 out of 5 NCEP metabolic syndrome criteria (fasting plasma glucose ¡Ý 6.1 mmol/l, triglycerides ¡Ý 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol < 1.04 mmol/l, blood pressure ¡Ý 130/85 mmHg)
Exclusion criteria
- Use of any medication, including proton pomp inhibitors and antibiotics in the past three months
- Cholecystectomy
- A history of cardiovascular event (MI or pacemaker implantation)
- (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).
- Unmotivated or not able to adhere to a specific diet.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL5828 |
| NTR-old | NTR5983 |
| Other | : METC 2016_117 |