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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Arabinoxylan oligosaccharides

Short chain fatty acids

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AXOS as first intervention

SCFA as first intervention

Arm Description

AXOS as first intervention

SCFA as first intervention

Outcomes

Primary Outcome Measures

Change in insulin resistance after both interventions using the homeostatic model assessment for insulin resistance

Secondary Outcome Measures

Full Information

NCT ID

NCT02623777

First Posted

November 28, 2015

Last Updated

December 3, 2015

Sponsor

KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT02623777

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AXOS as first intervention

Arm Type

Experimental

Arm Description

AXOS as first intervention

Arm Title

SCFA as first intervention

Arm Type

Experimental

Arm Description

SCFA as first intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

Arabinoxylan oligosaccharides

Other Intervention Name(s)

AXOS

Intervention Description

Arabinoxylan oligosaccharides administered

Intervention Type

Dietary Supplement

Intervention Name(s)

Short chain fatty acids

Other Intervention Name(s)

SCFA

Intervention Description

Short chain fatty acids administered

Primary Outcome Measure Information:

Title

Change in insulin resistance after both interventions using the homeostatic model assessment for insulin resistance

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

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

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