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

NCT02623777 | Completed

• 1 other identifier: s57413
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  2 weeks

Study Arms (2)

AXOS as first intervention

EXPERIMENTAL

AXOS as first intervention

Dietary Supplement: Arabinoxylan oligosaccharides; Dietary Supplement: Short chain fatty acids

SCFA as first intervention

EXPERIMENTAL

SCFA as first intervention

Dietary Supplement: Arabinoxylan oligosaccharides; Dietary Supplement: Short chain fatty acids

Interventions

Arabinoxylan oligosaccharides DIETARY_SUPPLEMENT

Arabinoxylan oligosaccharides administered

Also known as: AXOS

AXOS as first intervention; SCFA as first intervention

Short chain fatty acids DIETARY_SUPPLEMENT

Short chain fatty acids administered

Also known as: SCFA

AXOS as first intervention; SCFA as first intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Fatty Acids, Volatile

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Kristin Verbeke

Study Record Dates

• First Submitted: November 28, 2015
• First Posted: December 8, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12