Diabetes Mellitus, Type 2NCT03141710
Commercial Prebiotic Supplement Study
A study testing 20 ml of prebiotic per day in people with Diabetes Mellitus, Type 2, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Previous work in 2015/16 has identified changes in the gut microbiota with prebiotic (Molkosan®) supplement. It report significant changes in metabolic health bio-markers and faecal SCFA profile in 18 health adult subjects consuming 20 ml of product twice a day. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 20 ml of prebiotic per day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2017to 18 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance (IGT, identified by HbA1c) or type 2 diabetes (lifestyle management; identified by HbA1c) age 18-65, with BMI 18-40 kg m-2, measured at screening visit.
Who cannot join
- Type 1 Diabetes, Severe gastrointestinal disorders (IBD), Kidney disease, Thromboembolic or coagulation disease, Hepatic disease, Alcohol or any other substance abuse, Eating disorders, Unregulated thyroid disease, Antibiotic use within the last 3 months, including proscribed and prescribed use. Current probiotic use or prebiotic use. Medication for glucose regulation. Female with breast feeding.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Rowett Institute, Human Nutrition Unit
Aberdeen, AB25 2ZD
About this study
Official title: Effect of Prebiotic in Type 2 Diabetes (Diabetes and Health Study)
Previous work in 2015/16 has identified changes in the gut microbiota with prebiotic (Molkosan®) supplement. It report significant changes in metabolic health bio-markers and faecal SCFA profile in 18 health adult subjects consuming 20 ml of product twice a day. Improvement in fasting metabolic parameters was observed flowing the intervention period. A reduction on Total Cholesterol, Glucose, Triglycerides and Insulin was observed.
In this study, a lower dose (20ml/d) in subjects with type 2 diabetes will be examed, over an extended period of time (12 week period) to match the profile of the intended consumer and provide preliminary data to support a larger multi-centre trial.
Read the detailed description
The study will be conducted in males and females with type 2 diabetes managed by diet and lifestyle alone.
The participants who meet the inclusion and exclusion criteria of the study will attend a screening visit where they will complete a medical screening and sign the consent form for participation in the study. Participates will visit the Human Nutrition Unit at the Rowett Institute to provide samples at week 0 (baseline), week 6 and week 12.
Participants' height, weight, and blood pressure will also be recorded. The investigators will measure HbA1c by a finger prick blood sample to confirm whether participants are a prediabetic or type 2 diabetic subjects. A 3-day weighed intake food diary will be completed during the initial washout period (minimum of 7 days) of the study in order to note their normal eating habits. No probiotic or prebiotics to be consumed during washout period and study period.
During the study periods, participants will take 20ml of prebiotic daily over the 12 consecutive weeks.
For the study visits, each participant will undergo, on two separated occasions, an OGTT, with and without the product at week 0 (to assess acute effects, prior to chronic ingestion) and at week 12 (to assess acute effects after chronic ingestion). The two OGTTs (with and without test product) will be separated by a period of 48 hr. Thus, each participant will have four OGTTs during the study. To minimise systematic errors, one half of the participants will start with the test product OGTT and the other half will start without product OGTT. The starting order will be determined randomly. Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Together with OGTT, breath samples will be taken every 30 min for measuring hydrogen and methane.
Only one fasted blood sample will be taken at week 6 (OGTT will not be performed at week 6).
Finger prick blood sample will be taken at week 12 to monitor for changes in HbA1c levels after prebiotic supplement.
Plasma samples will be collected from all blood samples from OGTTs and week 6 blood sample. Plasma glucose and lipid profiles (total cholesterol, HDL, LDL and triglycerides) will be measured by KONI analysis at the University of Aberdeen. Insulin will be measured by ELISA by researchers. All the plasma samples which are taken before and after taking the prebiotic supplement also be analysed for GLP-1, GIP, c-peptide and glucagon analysis by luminex assay.
GLP-1 and GIP are incretins which are produced in the intestinal mucosa and are normally secreted when food is eaten in order to reduce glycaemic exclusion by causing an increase in insulin secretion. These incretins are involved in the early stage of the insulin secretory response however the plasma insulin response is also influenced by hepatic insulin extraction which GLP-1 and GIP measurement cannot determine, therefore to optimise this, C-peptide will be also measured in this study.
All the data will be compared before and after supplementation and values are presented by means ± standard deviations.
From the faecal samples, the SCFA content of the samples to be determined by capillary gas chromatography. SCFA to be quantified against authentic standards of acetate, propionate, butyrate, valerate and the branched chain fatty acids iso-butyrate and iso-valerate. The lower limit for reliable detection of each product is 0.2 mM. DNA to be extracted at University of Aberdeen using the FastDNA spin kit for faeces following the manufacturer's instructions and quantitative PCR (qPCR). Samples and standards are prepared in 96 well plate format, enabling the use of a multichannel pipettes for setting up the running plate. PCR primer sets and amplification conditions are as described in previous studies.
The complete dataset will be analysed and values will be presented as a mean value and standard deviation. Then the baseline value and the value after supplementation (at 6 and 12 weeks) will be compared. Statistically significantly differences will be calculated by statistician with power calculate.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 20 ml of prebiotic per day
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 ml of prebiotic per dayDietary supplement
12 volunteers will take 20ml of prebiotic per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 12 type 2 diabetes patients | Experimental | Long-term dietary (12 weeks) intervention of 20ml of prebiotic per day Receives: Dietary Supplement: 20 ml of prebiotic per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of oral glucose tolerance test (OGTT)
Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Plasma glucose level will be measured by KONI analysis and
Measured: At baseline and 12 weeks prebiotic consumption
Secondary outcomes (10)
Change of insulin levels
Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). insulin level will be measured by luminex assay.
Measured: At baseline, 6 weeks and 12 weeks prebiotic consumption
HbA1c measured by Alere Afinion™ AS100 Analyzer
The term HbA1c refers to glycated haemoglobin. It develops when haemoglobin, a protein within red blood cells that carries oxygen throughout the body. By measuring glycated haemoglobin (HbA1c) can indicate blood sugar levels.
Finger prick method will be introduced to collect the small amount of blood samples into the Alere Afinion™ AS100 Analyzer cartridge. Insert cartridge to the machine to read the data. Inclusion criteria will be the levels above 6 % (42mmol/mol). We will also measure HbA1c at 12 week to monitor for changes.
Measured: At baseline and 12 weeks prebiotic consumption
Change of BMI (kg/m^2) measurement
Weight or Body Mass is defined as the quantity of matter in the body, measured by weight (kg) i.e. the force that matter exerts under standard gravitational effect. Height (m) will be recorded for conjunction with weight measurements to calculate Body Mass Index (BMI) values.
Measured: At baseline and 12 weeks prebiotic consumption
Change of Total Cholesterol levels
Total cholesterol (HDL and LDL -Cholesterols) will be measured by KONI analysis at University of Aberdeen. Separately measured HDL- and LDL-cholesterols levels will be combined for total cholesterol levels.
Measured: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of GLP-1 levels
The incretin hormones, glucagon-like peptide-1 (GLP-1) secretion, contributes to glucose intolerance. GLP-1 levels will be measured by luminex assay.
Measured: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of GIP levels
Glucose-dependent insulinotropic polypeptide (GIP) is potentiate the insulin response to nutrients. Insulinotropic capacity of GIP is markedly diminished in type 2 diabetes. Incretin hormone GIP will be measured by luminex assay.
Measured: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of triglyceride levels
Triglyceride levels will be measured for identifying the lipid profiles. Triglyceride will be measured by KONI analysis.
Measured: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of C-peptide levels
C-peptide are involved to hepatic insulin extraction. C-peptide levels are measured by luminex assay.
Measured: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of glucagon levels
Glucagon levels will be measured by luminex assay.
Measured: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of fermentation markers
Breath samples will be measured hydrogen and methane levels
Measured: At baseline and 12 weeks prebiotic consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start10 May 2017
- Primary completion18 Jul 2017
- Study completion18 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20ml of prebiotic per day for 12 weeks
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra M Johnstone, PhD, Principal investigator, University of Aberdeen, The Rowett Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141710
- Sponsor's protocol ID
- Study 805
- Status last verified
- May 2026
- First submitted
- 8 Feb 2017
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401.
PubMed 7782892Kenteu B, Noubiap JJ, Etoa MC, Azabji-Kenfack M, Dehayem M, Sobngwi E. Acute glycaemic effects of co-trimoxazole at prophylactic dose in healthy adults. BMC Endocr Disord. 2016 Nov 15;16(1):62. doi: 10.1186/s12902-016-0142-6.
PubMed 27927207Marathe CS, Rayner CK, Lange K, Bound M, Wishart J, Jones KL, Kahn SE, Horowitz M. Relationships of the early insulin secretory response and oral disposition index with gastric emptying in subjects with normal glucose tolerance. Physiol Rep. 2017 Feb;5(4):e13122. doi: 10.14814/phy2.13122. Epub 2017 Feb 27.
PubMed 28242817Salonen A, Lahti L, Salojarvi J, Holtrop G, Korpela K, Duncan SH, Date P, Farquharson F, Johnstone AM, Lobley GE, Louis P, Flint HJ, de Vos WM. Impact of diet and individual variation on intestinal microbiota composition and fermentation products in obese men. ISME J. 2014 Nov;8(11):2218-30. doi: 10.1038/ismej.2014.63. Epub 2014 Apr 24.
PubMed 24763370Walker AW, Ince J, Duncan SH, Webster LM, Holtrop G, Ze X, Brown D, Stares MD, Scott P, Bergerat A, Louis P, McIntosh F, Johnstone AM, Lobley GE, Parkhill J, Flint HJ. Dominant and diet-responsive groups of bacteria within the human colonic microbiota. ISME J. 2011 Feb;5(2):220-30. doi: 10.1038/ismej.2010.118. Epub 2010 Aug 5.
PubMed 20686513Yanagimachi T, Fujita Y, Takeda Y, Honjo J, Sakagami H, Kitsunai H, Takiyama Y, Abiko A, Makino Y, Kieffer TJ, Haneda M. Dipeptidyl peptidase-4 inhibitor treatment induces a greater increase in plasma levels of bioactive GIP than GLP-1 in non-diabetic subjects. Mol Metab. 2016 Dec 31;6(2):226-231. doi: 10.1016/j.molmet.2016.12.009. eCollection 2017 Feb.
PubMed 28180064
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotic in Type 2 Diabetes (Diabetes and Health Study)
- ClinicalTrials.gov ID
- NCT03141710
- Acronym / sponsor ID
- Study 805
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous work in 2015/16 has identified changes in the gut microbiota with prebiotic (Molkosan®) supplement. It report significant changes in metabolic health bio-markers and faecal SCFA profile in 18 health adult subjects consuming 20 ml of product twice a day. Improvement in fasting metabolic parameters was observed flowing the intervention period. A reduction on Total Cholesterol, Glucose, Triglycerides and Insulin was observed.
In this study, a lower dose (20ml/d) in subjects with type 2 diabetes will be examed, over an extended period of time (12 week period) to match the profile of the intended consumer and provide preliminary data to support a larger multi-centre trial.
Detailed description
The study will be conducted in males and females with type 2 diabetes managed by diet and lifestyle alone.
The participants who meet the inclusion and exclusion criteria of the study will attend a screening visit where they will complete a medical screening and sign the consent form for participation in the study. Participates will visit the Human Nutrition Unit at the Rowett Institute to provide samples at week 0 (baseline), week 6 and week 12.
Participants' height, weight, and blood pressure will also be recorded. The investigators will measure HbA1c by a finger prick blood sample to confirm whether participants are a prediabetic or type 2 diabetic subjects. A 3-day weighed intake food diary will be completed during the initial washout period (minimum of 7 days) of the study in order to note their normal eating habits. No probiotic or prebiotics to be consumed during washout period and study period.
During the study periods, participants will take 20ml of prebiotic daily over the 12 consecutive weeks.
For the study visits, each participant will undergo, on two separated occasions, an OGTT, with and without the product at week 0 (to assess acute effects, prior to chronic ingestion) and at week 12 (to assess acute effects after chronic ingestion). The two OGTTs (with and without test product) will be separated by a period of 48 hr. Thus, each participant will have four OGTTs during the study. To minimise systematic errors, one half of the participants will start with the test product OGTT and the other half will start without product OGTT. The starting order will be determined randomly. Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Together with OGTT, breath samples will be taken every 30 min for measuring hydrogen and methane.
Only one fasted blood sample will be taken at week 6 (OGTT will not be performed at week 6).
Finger prick blood sample will be taken at week 12 to monitor for changes in HbA1c levels after prebiotic supplement.
Plasma samples will be collected from all blood samples from OGTTs and week 6 blood sample. Plasma glucose and lipid profiles (total cholesterol, HDL, LDL and triglycerides) will be measured by KONI analysis at the University of Aberdeen. Insulin will be measured by ELISA by researchers. All the plasma samples which are taken before and after taking the prebiotic supplement also be analysed for GLP-1, GIP, c-peptide and glucagon analysis by luminex assay.
GLP-1 and GIP are incretins which are produced in the intestinal mucosa and are normally secreted when food is eaten in order to reduce glycaemic exclusion by causing an increase in insulin secretion. These incretins are involved in the early stage of the insulin secretory response however the plasma insulin response is also influenced by hepatic insulin extraction which GLP-1 and GIP measurement cannot determine, therefore to optimise this, C-peptide will be also measured in this study.
All the data will be compared before and after supplementation and values are presented by means ± standard deviations.
From the faecal samples, the SCFA content of the samples to be determined by capillary gas chromatography. SCFA to be quantified against authentic standards of acetate, propionate, butyrate, valerate and the branched chain fatty acids iso-butyrate and iso-valerate. The lower limit for reliable detection of each product is 0.2 mM. DNA to be extracted at University of Aberdeen using the FastDNA spin kit for faeces following the manufacturer's instructions and quantitative PCR (qPCR). Samples and standards are prepared in 96 well plate format, enabling the use of a multichannel pipettes for setting up the running plate. PCR primer sets and amplification conditions are as described in previous studies.
The complete dataset will be analysed and values will be presented as a mean value and standard deviation. Then the baseline value and the value after supplementation (at 6 and 12 weeks) will be compared. Statistically significantly differences will be calculated by statistician with power calculate.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20ml of prebiotic per day for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| 12 type 2 diabetes patients | Experimental | Dietary Supplement: 20 ml of prebiotic per dayLong-term dietary (12 weeks) intervention of 20ml of prebiotic per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Impaired glucose tolerance (IGT, identified by HbA1c) or type 2 diabetes (lifestyle management; identified by HbA1c) age 18-65, with BMI 18-40 kg m-2, measured at screening visit.
Key exclusion criteria (1 listed)
- Type 1 Diabetes, Severe gastrointestinal disorders (IBD), Kidney disease, Thromboembolic or coagulation disease, Hepatic disease, Alcohol or any other substance abuse, Eating disorders, Unregulated thyroid disease, Antibiotic use within the last 3 months, including proscribed and prescribed use. Current probiotic use or prebiotic use. Medication for glucose regulation. Female with breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 ml of prebiotic per day12 volunteers will take 20ml of prebiotic per day for 12 weeks | Dietary supplement | 12 type 2 diabetes patients |
Primary outcome
Change of oral glucose tolerance test (OGTT)
Time frame: At baseline and 12 weeks prebiotic consumption
Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Plasma glucose level will be measured by KONI analysis and
10 secondary outcomes
Change of insulin levels
Time frame: At baseline, 6 weeks and 12 weeks prebiotic consumption
HbA1c measured by Alere Afinion™ AS100 Analyzer
Time frame: At baseline and 12 weeks prebiotic consumption
Change of BMI (kg/m^2) measurement
Time frame: At baseline and 12 weeks prebiotic consumption
Change of Total Cholesterol levels
Time frame: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of GLP-1 levels
Time frame: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of GIP levels
Time frame: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of triglyceride levels
Time frame: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of C-peptide levels
Time frame: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of glucagon levels
Time frame: At baseline, 6 weeks and 12 weeks prebiotic consumption
Change of fermentation markers
Time frame: At baseline and 12 weeks prebiotic consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 7782892Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401.
- Background: PubMed 27927207Kenteu B, Noubiap JJ, Etoa MC, Azabji-Kenfack M, Dehayem M, Sobngwi E. Acute glycaemic effects of co-trimoxazole at prophylactic dose in healthy adults. BMC Endocr Disord. 2016 Nov 15;16(1):62. doi: 10.1186/s12902-016-0142-6.
- Background: PubMed 28242817Marathe CS, Rayner CK, Lange K, Bound M, Wishart J, Jones KL, Kahn SE, Horowitz M. Relationships of the early insulin secretory response and oral disposition index with gastric emptying in subjects with normal glucose tolerance. Physiol Rep. 2017 Feb;5(4):e13122. doi: 10.14814/phy2.13122. Epub 2017 Feb 27.
- Background: PubMed 24763370Salonen A, Lahti L, Salojarvi J, Holtrop G, Korpela K, Duncan SH, Date P, Farquharson F, Johnstone AM, Lobley GE, Louis P, Flint HJ, de Vos WM. Impact of diet and individual variation on intestinal microbiota composition and fermentation products in obese men. ISME J. 2014 Nov;8(11):2218-30. doi: 10.1038/ismej.2014.63. Epub 2014 Apr 24.
- Background: PubMed 20686513Walker AW, Ince J, Duncan SH, Webster LM, Holtrop G, Ze X, Brown D, Stares MD, Scott P, Bergerat A, Louis P, McIntosh F, Johnstone AM, Lobley GE, Parkhill J, Flint HJ. Dominant and diet-responsive groups of bacteria within the human colonic microbiota. ISME J. 2011 Feb;5(2):220-30. doi: 10.1038/ismej.2010.118. Epub 2010 Aug 5.
- Background: PubMed 28180064Yanagimachi T, Fujita Y, Takeda Y, Honjo J, Sakagami H, Kitsunai H, Takiyama Y, Abiko A, Makino Y, Kieffer TJ, Haneda M. Dipeptidyl peptidase-4 inhibitor treatment induces a greater increase in plasma levels of bioactive GIP than GLP-1 in non-diabetic subjects. Mol Metab. 2016 Dec 31;6(2):226-231. doi: 10.1016/j.molmet.2016.12.009. eCollection 2017 Feb.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra M Johnstone, PhD principal investigator
University of Aberdeen, The Rowett Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 ml of prebiotic per day in people with Diabetes Mellitus, Type 2, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of oral glucose tolerance test (OGTT) (time frame: At baseline and 12 weeks prebiotic consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141710, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.