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van CCT (UK)

van CCT (UK)

The effect of arabinose on glycaemic responses in subjects at risk of developing type 2 diabetes.

- candidate number29736
- NTR NumberNTR7630
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2018
- Secondary IDsNL66558.081.18; 18/21 METC-WU
- Public TitleThe effect of arabinose on glycaemic responses in subjects at risk of developing type 2 diabetes.
- Scientific TitleThe effect of arabinose on glycaemic responses in subjects at risk of developing type 2 diabetes.
- ACRONYMAra4-studie
- hypothesisAddition of arabinose lowers glycemic repsonses in subjects at risk of developing type 2 diabetes
- Healt Condition(s) or Problem(s) studiedGlucose metabolism , Diabetes Mellitus Type 2 (DM type II), Metabolic health
- Inclusion criteria- Age range of ≥ 55 and < 80 years old,
- BMI ≥ 25 <40 kg/m2,
- Impaired fasting glucose (IFG; fasting glucose ≥ 5.6 and < 7.0 mmol/L) or
- HbA1C: ≥ 39 < 49 mmol/mol
- Exclusion criteria- Diagnosed with diabetes,
- Having other diseases, including amongst others liver, pancreas and endocrine diseases, which could affect the study results.
- Having gastro-intestinal problems,
- Use of medications or supplements that could influence the study results (chronic medications or supplements should be used as normal),
- Allergy, intolerance or oversensitivity for food products,
- Sensitive to medical skin adhesives,
- Following a medically prescribed, low energy or low carbohydrate diet,
- Unwilling to consume the provided diets,
- More than 5kg weight change in the last 3 months,
- Current antibiotics usage or in the two months prior to the first test day,
- Excessive alcohol consumption (>21 glasses/week for men and >14 glasses/week for women on average),
- Having blood vessels that are too difficult for inserting a cannula, as judged by the study nurse,
- Not normal haemoglobin (Hb) concentration <8.5 mmol/L for men and <7.5 mmol/L for women,
- Recent blood donation (<1 month prior to the first study day),
- Planning to donate blood as a blood donor during the study,
- Mentally incompetent or not being able to perform the measurements according to the protocol,
- Not having a general practitioner,
- Being an employee of Wageningen University, division of Human Nutrition and Health,
- Current participation in other research (except EetMeetWeet).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-nov-2018
- planned closingdate21-jan-2019
- Target number of participants18
- InterventionsSugar drink with and without arabinose. And arabinose supplementation during 2 days
- Primary outcomeblood glucose and insulin levels
- Secondary outcomecontinuous glucose during 48 h, appetite ratings, side effects
- TimepointsEvery subject will visit University 5 times, an information meeting, a screening including a fasting glucose, Hb and HbA1c, 2 test days and removal of the glucose sensor.
Plasma collection: 0, 15, 30, 45, 60, 90, 120, 180 minutes.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
EU grant
- Publications
- Brief summaryL-arabinose is a pentose which is naturally present in plants. L-arabinose is a sucrase inhibitor and thereby lowers glycaemic and insulinemic responses when consumed together with sucrose as a drink in young healthy subjects. Still, we donít know if this effect is also observed in subjects that are less able to regulate their glucose levels. Further, long term effects such as 24h or 48h glucose responses are scarce.The main objective is to determine the effect of drinking a solution of sucrose with arabinose on glycemic responses in prediabetic subjects. Secondary objectives are continuous glucose responses, appetite ratings, tolerance of the treatments, L-arabinose in the blood, and excretion of L-arabinose in urine. The study is a randomized double-blind cross-over study with a washout period of 5 days. Eighteen subjects between 55-80y old with increased risk of developing type II diabetes will be included. The drinks will be consumed in fasting state as a breakfast. Further, lemonades with or without arabinose will be provided to drink before every meal during 48h, when meanwhile continuous blood glucose is measured.
- Main changes (audit trail)
- RECORD29-okt-2018 - 10-dec-2018

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