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OpenTrials
Completed

NCT Number: NCT02623777

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arabinoxylan oligosaccharides

Dietary Supplement

Arabinoxylan oligosaccharides administered

Other names: AXOS

Short chain fatty acids

Dietary Supplement

Short chain fatty acids administered

Other names: SCFA

Primary outcomes

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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 8, 2015
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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