Enteral NutritionAlgiNGNCT04113200
Comparison of an Alginate Containing Enteral Feed and an Alginate Free Enteral Feed.
A study testing MerMed One and Nutricomp Soy Fibre in people with Enteral Nutrition, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
When patients cannot eat and drink enough a tube can be placed through their nostril, down the back of their throat into their stomach and used to give their nutrition as a liquid feed. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- MerMed One and Nutricomp Soy Fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2019to 30 Mar 2020
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non- smoking (non- vaping) males
- aged 18- 45 years
- body mass index (BMI) of 18.5-24.5kg/ m2 or a BMI of 24.5- 26kg/ m2
- a waist circumference of less than 94 cm.
- ability to give informed consent
Who cannot join
- A history of an acute illness, lasting more than a week, in the last six weeks;
- taking any medications for gastrointestinal disorders, including acid suppressants or anti-spasmodics,
- taking anti-depressants or symptoms of clinical depression (defined by a score >10 on the Beck Depression Inventory)
- taking medication for diabetes or having diabetes
- a history of substance abuse in the last six months;
- having any factors that preclude safe MRI;
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- a history of gastrointestinal disorders, including Gastro Oesophgeal Reflux Disease, Irritable Bowel Syndrome, active peptic ulcer disease; having diabetes;
- previous surgery to the gastrointestinal or biliary systems;
- having characteristics of those with an eating disorders (defined by a score of more than 20 on the Eating Attitudes Test (EAT-26));
- having an allergy or intolerance to the ingredients in the enteral feeds, or the cheese and tomato pasta meal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
Official title: Gastric, Biochemical, Endocrine and Appetitive Responses to an Enterally Fed Alginate-containing Feed, Compared With an Alginate Free Feed
When patients cannot eat and drink enough a tube can be placed through their nostril, down the back of their throat into their stomach and used to give their nutrition as a liquid feed. One of the commonest problems when using this tube is regurgitation of feed up from the stomach (gastro- oesophageal reflux (GOR)), or liquid stools (diarrhoea). This can cause the patient discomfort, a higher risk of getting a skin or chest infection, and increase the risk that the feed is stopped.
The investigators intend to investigate, in twelve healthy young men, whether adding a form of dietary fibre (alginate) to the feed could reduce these symptoms (diarrhoea and GOR), hence ensuring patients are properly nourished and recover as quickly as possible from their illness, Each volunteer will come to the lab twice and will have a tube inserted into the stomach via the nose so that they can be given both feeds. Each time, the investigators will take repeated pictures of how the feed is passing through their gut using a non invasive technique called 'magnetic resonance imaging' (MRI), take blood samples to see how quickly the nutrition is absorbed into the blood, and measure how hungry they feel
Read the detailed description
TRIAL / STUDY DESIGN Each participant will be required to attend a screening visit, a brief education visit re collecting dietary information, adhering to a standardised diet and faecal sample collection; two, approximately five hour, study visits with 7- 10 days between each visit; and a brief visit after each intervention day to return diet information and the faecal samples. Prior to the study visits they will be required to consume a standardised diet for four days, based on their usual intake with similar macronutrient composition to the feed. On each study visit they will be fed, via a nasogastric enteral tube, 300mls/ hour of one of two enteral feeds (total feed delivered 300mls). The gastric response will be measured using MRI scanning, the biochemical and endocrine response will be measured using arterialised venous blood samples, and the appetitive response will be measured using visual analogue scales, and direct measurement of food intake at an ad libitum test meal. Participants will continue to consume a standardised diet for 3 days after the delivery of the enteral feed. Faecal samples will be collected before and after the visit day, for pH measurement.
Ethical approval has been obtained from the Faculty of Medicine and Health Sciences Ethics Committee, University of Nottingham. All participants will provided informed, written consent.
- Conditions
- Enteral Nutrition
- Being tested
- MerMed One, Nutricomp Soy Fibre
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MerMed OneDietary supplement
A 1 kcal per ml enteral feed containing an alginate.
Nutricomp Soy FibreDietary supplement
A 1kcal per ml enteral feed not containing alginate.
| Study group | Role | What they receive |
|---|---|---|
| F+ALG | Experimental | An alginate containing feed: MerMed One (Kaneka Corporation). 300mls administered nasogastrically over one hour. Receives: Dietary Supplement: MerMed One |
| F-ALG | Other | A standard enteral feed commonly used in practice. Nutricomp Soy Fibre (B.Braun). 300mls administered nasogastrically over one hour. Receives: Dietary Supplement: Nutricomp Soy Fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel water response to feeding
Area under the curve for small bowel water measured by MRI over four hours from baseline.
Measured: After four hours from baseline
Secondary outcomes (14)
Gastric volume relative to baseline
Area under the curve for gastric volume relative to baseline, measured by MRI for four hours from baseline.
Measured: After four hours from baseline
Mean post feeding gastric emptying rate
Mean gastric emptying rate calculated from MRI images of gastric volume obtained over four hours from baseline.
Measured: Over four hours from baseline.
Superior mesenteric blood flow
Mean superior mesenteric blood flow calculated from measurements over four hours from baseline.
Measured: Over four hours from baseline.
Incremental area under the curve for arterialised whole blood glucose
Incremental area under the curve for arterialised whole blood glucose will be calculated using samples collected at 10 minute intervals between baseline and four hours.
Measured: Over four hours post baseline
Incremental area under the curve for insulin
Incremental area under the curve for insulin will be calculated using samples collected at 20 minute intervals between baseline and four hours.
Measured: Over four hours from baseline
Incremental area under the curve for PYY (Peptide YY)
Incremental area under the curve for PYY will be calculated using samples collected at 20 minute intervals between baseline and four hours.
Measured: Over four hours from baseline
Incremental area under the curve for Gastric Inhibitory Polypeptide
Incremental area under the curve for GIP will be calculated using samples collected at 20 minute intervals between baseline and four hours.
Measured: Over four hours from baseline
Incremental area under the curve for Glucagon-like peptide 1 (GLP- 1)
Incremental area under the curve for GLP-1 will be calculated using samples collected at 20 minute intervals between baseline and four hours.
Measured: Over four hours from baseline
Incremental area under the curve for Ghrelin
Incremental area under the curve for Ghrelin will be calculated using samples collected at 20 minute intervals between baseline and four hours.
Measured: Over four hours from baseline
Incremental area under the curve for composite satiety score
Composite satiety score will be calculated using 100mm visual analogue score ratings of satiety, fullness, hunger and prospective food consumption collected every 30 minutes between baseline and four hours.
Measured: Over four hours from baseline
Weight of consumption of a pasta meal four hours and thirty minutes after baseline.
Weight of pasta consumed from a bowl refilled prior to being empty until participants feel comfortably full.
Measured: Four hours and thirty minutes post baseline.
Change in Faecal pH from baseline
The difference between faecal pH pre feeding and post feeding will be compared.
Measured: Comparison between sample obtained immediately before the enteral feeding day and samples obtained during the three days following the enteral feeding day.
Faecal consistency
Rating of consistency of faecal sample will be compared with rating of consistency post enteral feeding day.
Measured: Comparison between sample obtained immediately before the enteral feeding day and samples obtained during the three days following the enteral feeding day.
Incremental area under the curve for gastric symptom scores rated using visual analogue scores.
Incremental area under the curve for gastric symptoms will be calculated using 100mm visual analogue score ratings obtained every half hour between baseline and four hours.
Measured: Over four hours from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start29 Jan 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive the control and intervention product according to randomised crossover design with a minimum washout period of 7 days.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Corporation
- Responsible party
- Principal investigator, Moira Taylor, University of Nottingham
- Investigators
- Moira Taylor, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113200
- Sponsor's protocol ID
- RGS129061
- Acronym
- AlgiNG
- Status last verified
- Sep 2022
- First submitted
- 11 Jul 2019
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric, Biochemical, Endocrine and Appetitive Responses to an Enterally Fed Alginate-containing Feed, Compared With an Alginate Free Feed
- ClinicalTrials.gov ID
- NCT04113200
- Acronym / sponsor ID
- AlgiNG / RGS129061
- Conditions
- Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Kaneka Corporation
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 2 Oct 2019 (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.
When patients cannot eat and drink enough a tube can be placed through their nostril, down the back of their throat into their stomach and used to give their nutrition as a liquid feed. One of the commonest problems when using this tube is regurgitation of feed up from the stomach (gastro- oesophageal reflux (GOR)), or liquid stools (diarrhoea). This can cause the patient discomfort, a higher risk of getting a skin or chest infection, and increase the risk that the feed is stopped.
The investigators intend to investigate, in twelve healthy young men, whether adding a form of dietary fibre (alginate) to the feed could reduce these symptoms (diarrhoea and GOR), hence ensuring patients are properly nourished and recover as quickly as possible from their illness, Each volunteer will come to the lab twice and will have a tube inserted into the stomach via the nose so that they can be given both feeds. Each time, the investigators will take repeated pictures of how the feed is passing through their gut using a non invasive technique called 'magnetic resonance imaging' (MRI), take blood samples to see how quickly the nutrition is absorbed into the blood, and measure how hungry they feel
Detailed description
TRIAL / STUDY DESIGN Each participant will be required to attend a screening visit, a brief education visit re collecting dietary information, adhering to a standardised diet and faecal sample collection; two, approximately five hour, study visits with 7- 10 days between each visit; and a brief visit after each intervention day to return diet information and the faecal samples. Prior to the study visits they will be required to consume a standardised diet for four days, based on their usual intake with similar macronutrient composition to the feed. On each study visit they will be fed, via a nasogastric enteral tube, 300mls/ hour of one of two enteral feeds (total feed delivered 300mls). The gastric response will be measured using MRI scanning, the biochemical and endocrine response will be measured using arterialised venous blood samples, and the appetitive response will be measured using visual analogue scales, and direct measurement of food intake at an ad libitum test meal. Participants will continue to consume a standardised diet for 3 days after the delivery of the enteral feed. Faecal samples will be collected before and after the visit day, for pH measurement.
Ethical approval has been obtained from the Faculty of Medicine and Health Sciences Ethics Committee, University of Nottingham. All participants will provided informed, written consent.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will receive the control and intervention product according to randomised crossover design with a minimum washout period of 7 days.
| Arm | Type | Receives |
|---|---|---|
| F+ALG | Experimental | Dietary Supplement: MerMed OneAn alginate containing feed: MerMed One (Kaneka Corporation). 300mls administered nasogastrically over one hour. |
| F-ALG | Other | Dietary Supplement: Nutricomp Soy FibreA standard enteral feed commonly used in practice. Nutricomp Soy Fibre (B.Braun). 300mls administered nasogastrically over one hour. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non- smoking (non- vaping) males
- aged 18- 45 years
- body mass index (BMI) of 18.5-24.5kg/ m2 or a BMI of 24.5- 26kg/ m2
- a waist circumference of less than 94 cm.
- ability to give informed consent
Key exclusion criteria (10 listed)
- A history of an acute illness, lasting more than a week, in the last six weeks;
- taking any medications for gastrointestinal disorders, including acid suppressants or anti-spasmodics,
- taking anti-depressants or symptoms of clinical depression (defined by a score >10 on the Beck Depression Inventory)
- taking medication for diabetes or having diabetes
- a history of substance abuse in the last six months;
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 |
|---|---|---|
| MerMed OneA 1 kcal per ml enteral feed containing an alginate. | Dietary supplement | F+ALG |
| Nutricomp Soy FibreA 1kcal per ml enteral feed not containing alginate. | Dietary supplement | F-ALG |
Primary outcome
Small bowel water response to feeding
Time frame: After four hours from baseline
Area under the curve for small bowel water measured by MRI over four hours from baseline.
14 secondary outcomes
Gastric volume relative to baseline
Time frame: After four hours from baseline
Mean post feeding gastric emptying rate
Time frame: Over four hours from baseline.
Superior mesenteric blood flow
Time frame: Over four hours from baseline.
Incremental area under the curve for arterialised whole blood glucose
Time frame: Over four hours post baseline
Incremental area under the curve for insulin
Time frame: Over four hours from baseline
Incremental area under the curve for PYY (Peptide YY)
Time frame: Over four hours from baseline
Incremental area under the curve for Gastric Inhibitory Polypeptide
Time frame: Over four hours from baseline
Incremental area under the curve for Glucagon-like peptide 1 (GLP- 1)
Time frame: Over four hours from baseline
Incremental area under the curve for Ghrelin
Time frame: Over four hours from baseline
Incremental area under the curve for composite satiety score
Time frame: Over four hours from baseline
Weight of consumption of a pasta meal four hours and thirty minutes after baseline.
Time frame: Four hours and thirty minutes post baseline.
Change in Faecal pH from baseline
Time frame: Comparison between sample obtained immediately before the enteral feeding day and samples obtained during the three days following the enteral feeding day.
Faecal consistency
Time frame: Comparison between sample obtained immediately before the enteral feeding day and samples obtained during the three days following the enteral feeding day.
Incremental area under the curve for gastric symptom scores rated using visual analogue scores.
Time frame: Over four hours from baseline.
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 23 Sep 2022.
- Individual participant dataSharing planned: Yes. Only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis.
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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.
Moira Taylor, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MerMed One and Nutricomp Soy Fibre in people with Enteral Nutrition, run by University of Nottingham 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 5 inclusion and 10 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 23 Sep 2022. 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?
Small bowel water response to feeding (time frame: After four hours from baseline). 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 23 Sep 2022.