Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Arabinoxylan oligosaccharides; Dietary Supplement: Short chain fatty acids

• Registration Number: NCT02623777
• Lead Sponsor: KU Leuven

Brief Summary

During this project the investigators will evaluate whether the effects of arabinoxylan oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the investigators will evaluate whether changes in gut hormone production might explain the effect on insulin resistance.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Study First Submitted: 2015-11-28
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-03
• Last Update Submitted: 2015-12-03
• Study First Posted: 2015-12-08
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Age between 18 and 65 years

• Regular diet (3 meals/day on at least 5 days/week)

• Central obese (defined as waist circumference ≥ 94cm for Europid men and ≥ 80cm for Europid women, with ethnicity specific values for other groups)

• Insulin resistant: HOMA-IR > 1.7 or fasting glucose > 100mg/dL

• And one of the following three factors:

  • Elevated TG level: ≥ 150 mg/dL (1.7 mmol/L)
  • Decreased HDL cholesterol level: < 40 mg/dL (1.03 mmol/L*) in males and < 50 mg/dL (1.29 mmol/L*) in females
  • Elevated blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg

Exclusion Criteria

• Low calorie diet or other special diet during the study or during the last month prior to the study
• Serious chronic disease of the gastrointestinal tract, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), irritable bowel syndrome, chronic constipation (less than 3 bowel movements a week), chronic frequent diarrhoea (more than 3 stools a day), clinically relevant lactose intolerance, ...
• Use of antibiotics during the last month before starting the study
• Abdominal surgery in the past (except from appendectomy)
• Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication, and/or pre- or probiotic supplements (e.g. lacteol, Enterol)
• Pregnancy, pregnancy desire or lactation
• Diabetes (type 1 or 2), i.e. HbA1c > 6.5 %
• Abnormal haemoglobin (Hb) levels in blood, men must have an Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AXOS as first intervention	Arabinoxylan oligosaccharides	AXOS as first intervention
AXOS as first intervention	Short chain fatty acids	AXOS as first intervention
SCFA as first intervention	Short chain fatty acids	SCFA as first intervention
SCFA as first intervention	Arabinoxylan oligosaccharides	SCFA as first intervention

Primary Outcome Measures

Name	Time	Method
Change in insulin resistance after both interventions using the homeostatic model assessment for insulin resistance	2 weeks