Gut MicrobiotaITFNCT02827760
The Effect of Prebiotic Synergy1 Supplementation on Microbiota, Protein Metabolism and Gastrointestinal (GI) Symptoms in People Consuming High Protein Diet
A study testing Synergy1 and Maltodextrin in people with Gut Microbiota, run by University of Reading at 1 site in United Kingdom.
Trial summary
The composition and metabolism of human gut microbiota play crucial roles in health. Microbial colonisation of the gastrointestinal tract varies widely, with the large intestine having not only the highest density of microbes in terms of bacterial cells per gram but also the most metabolically active microbial… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- Synergy1 and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health.
- Having high protein diet.
- The volunteer has given written informed consent to participate and is willing to participate in the entire study.
Who cannot join
- History or evidence of intestinal disease; such as tumour, Irritable Bowel Syndrome, etc., within the previous 5 years.
- Received antibiotics in the previous six months
- Not willing to cease the consumption of probiotic or prebiotic preparations for the duration of the study
- Former participation in another study involving prebiotic or probiotic preparations within the previous 2-weeks, or intention to use such products during the course of the study (please note sensory evaluations may be still permitted after discussion with the Investigator)
- History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
- Diabetes
Show all 15Show fewer
- Smoker
- Lactose intolerant
- Allergic to gluten
- Currently prescribed immunosuppressive drugs.
- Participants will be required to withdraw should they begin taking any of the ineligible medication.
- Intention to use regularly other medication which affects gastrointestinal motility.
- History of alcohol or drug misuse.
- Using statins
- Suffer from any major conditions involving the following: Head, Ears, Eyes, Nose and Throat, Dermatological/Connective tissue, Neurological, Lymphatic, Urogenital/Rectal, Abdominal, Respiratory, A previous cardiovascular event within the last 6 months, presence of secondary dyslipemia related to thyroid dysfunction, used any drug affecting lipid metabolism in previous 3 months, a history of alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Food and Nutritional sciences
Reading, Berkshire, RG6 6UR
About this study
The composition and metabolism of human gut microbiota play crucial roles in health. Microbial colonisation of the gastrointestinal tract varies widely, with the large intestine having not only the highest density of microbes in terms of bacterial cells per gram but also the most metabolically active microbial community. Genetics, mode of birth, infant feeding patterns, antibiotic usage, sanitary living conditions and long term dietary habits contribute towards shaping the composition of the gut microbiome. Diet clearly has a major impact on variation in the gut microbiota composition, and this can be detected in faecal samples after only a few days. The bacterial metabolism of dietary components produces much chemical diversity in the large intestine with protective or detrimental effects on disease development.
Dietary protein levels are relatively high in western European populations, up to 103g/d, as reported by Food and Agriculture Organization. This may result in high levels, entering the large gut where it can become a substrate for proteolytic bacteria. Protein specifically can provide nutrition for microorganisms but metabolites from bacterial protein breakdown can be detrimental. Protein intake from the diet might not be the only source of microbial proteolysis; the human body also secretes considerable amounts of protein into the digestive lumen which can potentially be used by the microflora. On the contrary, end products of carbohydrate metabolism can be positive for health. In this context, prebiotics are carbohydrates that are resistant to digestion and can become available for bacteria in the colon to produce short chain fatty acids and inhibit the production of harmful metabolites. A switch towards more carbohydrate metabolism in the colon, at the expense of proteolysis therefore has positive capacity through the production of more benign metabolites.
Read more
Rationale for design Prebiotics are dietary ingredients that target carbohydrate digesting bacteria only. Given the high intake levels of protein in Western populations, they may be useful to modulate the composition/activity of the microbial gut ecology for improved health.
Among prebiotic nutrients, inulin-type fructans (ITF) are well characterized and their administration promotes growth of beneficial microorganisms like Bifidobacterium spp. .These microorganisms are involved in the reduction of intestinal endotoxin concentration, improve glucose tolerance, exert benefits upon immune function and inhibit pathogens. In healthy individuals, ITF intake promotes satiety and modulates gut peptides regulating food intake.
The aim of the present study is to investigate the effect of inulin-type fructans (ITF) on the negative consequences of colonic fermentation in individuals consuming high protein diets. The hypothesis to be tested is that their action promotes carbohydrate degrading bacteria at the expense of protein utilisers.
- Conditions
- Gut Microbiota
- Being tested
- Synergy1, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synergy1Dietary supplement
Inulin type fructans
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin DE19 | Placebo comparator | Placebo Receives: Dietary Supplement: Maltodextrin |
| Prebiotic Synergy1 | Active comparator | Effective prebiotic Receives: Dietary Supplement: Synergy1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on the faecal microbiota composition by fluorescence in situ hybridisation
Changes in faecal bacterial populations will be assessed through the use of fluorescence in situ hybridisation with molecular probes targeting 16S rRNA genes. Genotypic probes targeting the predominant components of the gut microflora (Bacteroides, Bifidobacterium, Clostridium, Lactobacillus, Eubacterium, Atopobacterium, sulphate reducing bacteria and enterobacteria) and total bacteria will be tagged with fluorescent markers such that quantifiable changes may be determined.
Measured: 12 months
Effect on faecal microbiota activity using NMR
Relative abundance of various metabolites will be analysed by Nuclear magnetic resonance spectroscopy (NMR).
Measured: 12 months
Changes in faecal water short chain fatty acids (SCFAs) using gas chromatography
Concentrations of short chain fatty acids (SCFAs) will be quantified using gas chromatography (GC).
Measured: 12 months
Secondary outcomes (2)
Daily assessment of stools consistency
Stool consistency will be scored based on Bristol chart.
Measured: 12 months
Daily assessment of gastrointestinal symptoms
Number of abnormal pain, bloating or flatulence will be recorded.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuedan Wang, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827760
- Sponsor's protocol ID
- IFTPRO00
- Acronym
- ITF
- Status last verified
- May 2021
- First submitted
- 14 Jun 2016
- Last updated
- 6 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prebiotic Synergy1 Supplementation on Microbiota, Protein Metabolism and Gastrointestinal (GI) Symptoms in People Consuming High Protein Diet
- ClinicalTrials.gov ID
- NCT02827760
- Acronym / sponsor ID
- ITF / IFTPRO00
- Conditions
- Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
The composition and metabolism of human gut microbiota play crucial roles in health. Microbial colonisation of the gastrointestinal tract varies widely, with the large intestine having not only the highest density of microbes in terms of bacterial cells per gram but also the most metabolically active microbial community. Genetics, mode of birth, infant feeding patterns, antibiotic usage, sanitary living conditions and long term dietary habits contribute towards shaping the composition of the gut microbiome. Diet clearly has a major impact on variation in the gut microbiota composition, and this can be detected in faecal samples after only a few days. The bacterial metabolism of dietary components produces much chemical diversity in the large intestine with protective or detrimental effects on disease development.
Dietary protein levels are relatively high in western European populations, up to 103g/d, as reported by Food and Agriculture Organization. This may result in high levels, entering the large gut where it can become a substrate for proteolytic bacteria. Protein specifically can provide nutrition for microorganisms but metabolites from bacterial protein breakdown can be detrimental. Protein intake from the diet might not be the only source of microbial proteolysis; the human body also secretes considerable amounts of protein into the digestive lumen which can potentially be used by the microflora. On the contrary, end products of carbohydrate metabolism can be positive for health. In this context, prebiotics are carbohydrates that are resistant to digestion and can become available for bacteria in the colon to produce short chain fatty acids and inhibit the production of harmful metabolites. A switch towards more carbohydrate metabolism in the colon, at the expense of proteolysis therefore has positive capacity through the production of more benign metabolites.
Rationale for design Prebiotics are dietary ingredients that target carbohydrate digesting bacteria only. Given the high intake levels of protein in Western populations, they may be useful to modulate the composition/activity of the microbial gut ecology for improved health.
Among prebiotic nutrients, inulin-type fructans (ITF) are well characterized and their administration promotes growth of beneficial microorganisms like Bifidobacterium spp. .These microorganisms are involved in the reduction of intestinal endotoxin concentration, improve glucose tolerance, exert benefits upon immune function and inhibit pathogens. In healthy individuals, ITF intake promotes satiety and modulates gut peptides regulating food intake.
The aim of the present study is to investigate the effect of inulin-type fructans (ITF) on the negative consequences of colonic fermentation in individuals consuming high protein diets. The hypothesis to be tested is that their action promotes carbohydrate degrading bacteria at the expense of protein utilisers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin DE19 | Placebo comparator | Dietary Supplement: MaltodextrinPlacebo |
| Prebiotic Synergy1 | Active comparator | Dietary Supplement: Synergy1Effective prebiotic |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- In good general health.
- Having high protein diet.
- The volunteer has given written informed consent to participate and is willing to participate in the entire study.
Key exclusion criteria (15 listed)
- History or evidence of intestinal disease; such as tumour, Irritable Bowel Syndrome, etc., within the previous 5 years.
- Received antibiotics in the previous six months
- Not willing to cease the consumption of probiotic or prebiotic preparations for the duration of the study
- Former participation in another study involving prebiotic or probiotic preparations within the previous 2-weeks, or intention to use such products during the course of the study (please note sensory evaluations may be still permitted after discussion with the Investigator)
- History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
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 |
|---|---|---|
| Synergy1Inulin type fructans | Dietary supplement | Prebiotic Synergy1 |
| Maltodextrin | Dietary supplement | Maltodextrin DE19 |
Primary outcome
Changes on the faecal microbiota composition by fluorescence in situ hybridisation
Time frame: 12 months
Changes in faecal bacterial populations will be assessed through the use of fluorescence in situ hybridisation with molecular probes targeting 16S rRNA genes. Genotypic probes targeting the predominant components of the gut microflora (Bacteroides, Bifidobacterium, Clostridium, Lactobacillus, Eubacterium, Atopobacterium, sulphate reducing bacteria and enterobacteria) and total bacteria will be tagged with fluorescent markers such that quantifiable changes may be determined.
Effect on faecal microbiota activity using NMR
Time frame: 12 months
Relative abundance of various metabolites will be analysed by Nuclear magnetic resonance spectroscopy (NMR).
Changes in faecal water short chain fatty acids (SCFAs) using gas chromatography
Time frame: 12 months
Concentrations of short chain fatty acids (SCFAs) will be quantified using gas chromatography (GC).
2 secondary outcomes
Daily assessment of stools consistency
Time frame: 12 months
Daily assessment of gastrointestinal symptoms
Time frame: 12 months
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 6 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synergy1 and Maltodextrin in people with Gut Microbiota, run by University of Reading 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 3 inclusion and 15 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 6 May 2021. 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. Some participants in this study may receive a placebo. 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?
Changes on the faecal microbiota composition by fluorescence in situ hybridisation (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.