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

NCT ID: NCT02623777

Last Updated: 2015-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-11-30

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

AXOS as first intervention

AXOS as first intervention

Group Type: EXPERIMENTAL

Arabinoxylan oligosaccharides

Intervention Type: DIETARY_SUPPLEMENT

Arabinoxylan oligosaccharides administered

Short chain fatty acids

Intervention Type: DIETARY_SUPPLEMENT

Short chain fatty acids administered

SCFA as first intervention

SCFA as first intervention

Group Type: EXPERIMENTAL

Arabinoxylan oligosaccharides

Intervention Type: DIETARY_SUPPLEMENT

Arabinoxylan oligosaccharides administered

Short chain fatty acids

Intervention Type: DIETARY_SUPPLEMENT

Short chain fatty acids administered

Interventions

Arabinoxylan oligosaccharides

Arabinoxylan oligosaccharides administered

Intervention Type: DIETARY_SUPPLEMENT

Short chain fatty acids

Short chain fatty acids administered

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

AXOS; SCFA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Kristin Verbeke

Prof. Kristin Verbeke

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

s57413

Identifier Type: -

Identifier Source: org_study_id