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

Metabolic Syndrome Clinical Trial

Official title:

Evaluation of the Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome and the Contribution of Short-chain Fatty Acids Production

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623777
• Other study ID #: s57413
• Status: Completed
• Phase: N/A
• First received: November 28, 2015
• Last updated: December 3, 2015
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Arabinoxylan oligosaccharides
Arabinoxylan oligosaccharides administered
• Short chain fatty acids
Short chain fatty acids administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin resistance after both interventions using the homeostatic model assessment for insulin resistance		2 weeks	No