Overweight and ObesitySATINNCT02604316
SATIN: Satiety Innovation. Study 2- University of Aberdeen
A study testing Arabinoxylan and Beta- Glucan in people with Overweight and Obesity, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The proposed study will address the effect of developed novel food products through processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability and gut health using in vivo studies and validating new in vivo approaches. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Arabinoxylan and Beta- Glucan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females
- 18-65 years old
- Body Mass Index (BMI) 27-42kg/m2
- Overall healthy
- Weight Stable (<3 kg change in the past 4 months, before the trial).
Who cannot join
- Medical:
- Heavy smokers (more than 10 cigarettes/day) or heavy alcohol consumers (more than 4 alcohol units/day for male and more than 3 alcohol units/day for female).
- Obesity of endocrine origin.
- Chronic metabolic conditions: diabetes, hepatic disease, gout, kidney, thyroid or coagulation disease.
- Gastrointestinal disorders: celiac disease, Intenstinal Bowel Disease (IBD), irritable bowel syndrome (IBS), chronic constipation, diverticulitis, history of gastric bezoar. Suspected strictures, fistulas, or physiological GI obstruction.
- Psychiatric disorder: severe depression, bulimia, anorexia, schizophrenia, bipolar disorder.
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- Gastrointestinal procedure or surgery in the past three months.
- Disorders of swallowing, severe dysphagia to food or pills.
- Pregnancy
- Medication exclusion criteria
- Appetite modulator drugs: orlistat, sibutramine, rimonabant.
- Mood disorder medications: antidepressants, lithium.
- Others: oral antidiabetics, insulin, digoxin, thyroid hormones, antibiotics, steroids or immunosuppressants, recreational substances.
- Use of implanted or portable electro-mechanical device such as cardiac peacemaker or infusion pump.
- Blood donor in the past 3 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition and Health. University of Aberdeen
Aberdeen, AB219SB
About this study
Official title: SATIN: Satiety Innovation, Study 2. Effect of Novel Fibres (Arabinoxylan and Beta-glucan) in Appetite, Metabolic and Gut Health.
The proposed study will address the effect of developed novel food products through processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability and gut health using in vivo studies and validating new in vivo approaches.
Specifically in this protocol the investigators will address, in a short human intervention study the effect of a potentially satiating product on appetite, appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of the products in healthy obese and overweight participants in free living conditions.
Read the detailed description
Previous research has suggested that food structure and food composition has a role to play in controlling consumption. Low-energy, high-fibre diets provide physical bulk in the gastro-intestinal tract to sustain fullness in a way that low-volume, energy-dense foods cannot. However, studies shown low long term acceptability be probably associated to its poor palatability. Taste and hedonic experience remain the main drivers of consumer choice, and the immediate sensory aspect of food products such as palatability to have greater salience to consumers than their health promoting properties.
Changing the properties of foods merely by changing oro-sensory properties and through the delay of gastric emptying deals with mechanisms critical to within-meal satiation and early post meal satiety and may produce only transient suppression of hunger unless regularly consumed and represent benefits in delivering nutritional stimuli to key parts of the gastro-intestinal tract. The potential to manufacture change can make food structure variety now seem near limitless due the numerous advances in food technology.
Several recent reports have associated satiety effects with fermentable fibre sources in human dietary studies. Apparently, the large intestine microbiota recovers 'extra' calories from the diet and might contributes to obesity. However, the different mechanisms involved in lean and obese subjects are not completely resolved. Recent evidence in experimental animal designs indicates that changes in gut microbiota composition may be associated with increased food intake and obesity suggesting that satiety and intake are influenced by the species composition of the gut microbiota.
This short-term human nutrition study comprises in a randomised, cross-over design testing either two potentially satiety product, Arabinoxylan (A) or Beta-glucan (B) against an equivalent amount of heterogeneous natural fibre (Control) in 40 healthy-obese volunteers, aged 18-65 years old, BMI between 27 and 42Kg/m2 from both genders after an initial maintenance diet in free- living conditions.
Dietary intake, body weight, blood pressure would be monitored through the study. Faecal, urine and blood samples will be collected to monitor, glucose, insulin, gut peptides and assess metabolites of dietary and microbial origin. Orocecal Transit Time (OCTT), carbohydrate fermentability and methanogen status will be estimated using a breath test and transit time will be determined using SmartPill™.
- Conditions
- Overweight and Obesity
- Being tested
- Arabinoxylan, Beta- Glucan
- Keywords
- Overweight and Obesity, Appetite, Gut hormones and obesity, Arabinoxylan, Beta-Glucan, SmartPill
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArabinoxylanOther
Also called MC- NAXUS
10 days of weight loss diet calculated as 100% RMR + 15g Arabinoxylan (Medium Chain Naxus, BioActor b.v., Netherlands) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40% carbohydrate.
Beta- GlucanOther
Also called Viscofiber
10 days of weight loss diet calculated as 100% RMR + 6g β-glucan (Viscofibre, Naturex SA, France) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40%
| Study group | Role | What they receive |
|---|---|---|
| Arabinoxylan | Experimental | 10 days of weight loss diet calculated as 100% RMR + 15g Arabinoxylan (Medium Chain Naxus, BioActor b.v., Netherlands) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40% carbohydrate Receives: Other: Arabinoxylan |
| Control- Non Arabinoxylan | No intervention | 10 days of weight loss diet calculated 100% RMR using a heterogeneous natural fibre for food ingredients, 30% protein, 30% fat, 40% CHO. |
| Beta-Glucan | Experimental | 10 days of weight loss diet calculated as 100% RMR AND 6g Beta-Glucan (Viscofibre, Naturex SA, France) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40% Receives: Other: Beta- Glucan |
| Control Non Beta glucan | No intervention | 10 days of weight loss diet calculated 100% RMR using a heterogeneous natural fibre for food ingredients, 30% protein, 30% fat, 40% CHO. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Arabinoxylan or Beta- Glucan on weight loss and body composition
During this part of the study the effect of novel fibre of 3 dietary interventions subsequent each other: Maintenance (3 days), Arabinoxylan or Beta glucan per 10 days and Control diet per 10 days. Weight loss will be assessed after dietary intervention. Changes on body weight, BMI and total and regional body composition information using a two compartment model (fat mass and fat free mass by air displacement densitometry -Bod-Pod) will be assessed at the end of each dietary intervention. Resting Metabolic Rate will be assessed the beginning and at the end of the weight loss diet (Deltatrac).
Measured: 72 hours
Secondary outcomes (1)
Effect of Arabinoxylan or Beta- Glucan on gut health
The effect of a novel fibre on gut health: Gut microbiota, short chain fatty acids production.
To assess metabolites of dietary and microbial origin including short chain fatty acid. Bacterial community structure will be assessed by targeted quantitative polymerase chain reaction (qPCR), high throughput 454 sequencing (Walker et al., ISME J 2010) and 4',6-diamidino-2-phenylindole (DAPI) staining to estimate total bacteria. Gut transit will be assessed once at the end of each diet using a wireless motility device (SmartPill™). Only 4 volunteers will receive this assessment during the last 5 days of each maintenance period.
Questionnaires will be provided to monitor qualitatively gastrointestinal wellbeing during each dietary intervention.
Measured: 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Københavns Universitet, University of Leeds, University of Liverpool, Universidad de Murcia, University Rovira i Virgili, Karolinska Institutet, Cargill, The Coca-Cola Company, Juver Alimentación S.L.U, Naturex, Spain, Axxam S.p.A., BioActor, Centro Tecnológico Nacional Agroalimentario Extremadura, Centro Tecnológico Nacional de la Conserva y Alimentación, NIZO Food Research, RTD Services Vienna, ProDigest
- Responsible party
- Sponsor
- Investigators
- Dr Alexandra M Johnstone, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604316
- Sponsor's protocol ID
- 2/063/13
- Other IDs
- 289800, R&D
- Acronym
- SATIN
- Status last verified
- Sep 2016
- First submitted
- 26 Mar 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SATIN: Satiety Innovation, Study 2. Effect of Novel Fibres (Arabinoxylan and Beta-glucan) in Appetite, Metabolic and Gut Health.
- ClinicalTrials.gov ID
- NCT02604316
- Acronym / sponsor ID
- SATIN / 2/063/13
- Conditions
- Overweight and Obesity
- Keywords
- Overweight and Obesity, Appetite, Gut hormones and obesity, Arabinoxylan, Beta-Glucan, SmartPill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Københavns Universitet, University of Leeds, University of Liverpool, Universidad de Murcia, University Rovira i Virgili, Karolinska Institutet, Cargill, The Coca-Cola Company, Juver Alimentación S.L.U, Naturex, Spain, Axxam S.p.A., BioActor, Centro Tecnológico Nacional Agroalimentario Extremadura, Centro Tecnológico Nacional de la Conserva y Alimentación, NIZO Food Research, RTD Services Vienna, ProDigest
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Nov 2015 (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 proposed study will address the effect of developed novel food products through processing innovation on motivation to eat, biomarkers of satiety, nutrient bioavailability and gut health using in vivo studies and validating new in vivo approaches.
Specifically in this protocol the investigators will address, in a short human intervention study the effect of a potentially satiating product on appetite, appetite biomarkers, particularly the influence on gut microbiota, tolerance and safety of the products in healthy obese and overweight participants in free living conditions.
Detailed description
Previous research has suggested that food structure and food composition has a role to play in controlling consumption. Low-energy, high-fibre diets provide physical bulk in the gastro-intestinal tract to sustain fullness in a way that low-volume, energy-dense foods cannot. However, studies shown low long term acceptability be probably associated to its poor palatability. Taste and hedonic experience remain the main drivers of consumer choice, and the immediate sensory aspect of food products such as palatability to have greater salience to consumers than their health promoting properties.
Changing the properties of foods merely by changing oro-sensory properties and through the delay of gastric emptying deals with mechanisms critical to within-meal satiation and early post meal satiety and may produce only transient suppression of hunger unless regularly consumed and represent benefits in delivering nutritional stimuli to key parts of the gastro-intestinal tract. The potential to manufacture change can make food structure variety now seem near limitless due the numerous advances in food technology.
Several recent reports have associated satiety effects with fermentable fibre sources in human dietary studies. Apparently, the large intestine microbiota recovers 'extra' calories from the diet and might contributes to obesity. However, the different mechanisms involved in lean and obese subjects are not completely resolved. Recent evidence in experimental animal designs indicates that changes in gut microbiota composition may be associated with increased food intake and obesity suggesting that satiety and intake are influenced by the species composition of the gut microbiota.
This short-term human nutrition study comprises in a randomised, cross-over design testing either two potentially satiety product, Arabinoxylan (A) or Beta-glucan (B) against an equivalent amount of heterogeneous natural fibre (Control) in 40 healthy-obese volunteers, aged 18-65 years old, BMI between 27 and 42Kg/m2 from both genders after an initial maintenance diet in free- living conditions.
Dietary intake, body weight, blood pressure would be monitored through the study. Faecal, urine and blood samples will be collected to monitor, glucose, insulin, gut peptides and assess metabolites of dietary and microbial origin. Orocecal Transit Time (OCTT), carbohydrate fermentability and methanogen status will be estimated using a breath test and transit time will be determined using SmartPill™.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arabinoxylan | Experimental | Other: Arabinoxylan10 days of weight loss diet calculated as 100% RMR + 15g Arabinoxylan (Medium Chain Naxus, BioActor b.v., Netherlands) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40% carbohydrate |
| Control- Non Arabinoxylan | No intervention | –10 days of weight loss diet calculated 100% RMR using a heterogeneous natural fibre for food ingredients, 30% protein, 30% fat, 40% CHO. |
| Beta-Glucan | Experimental | Other: Beta- Glucan10 days of weight loss diet calculated as 100% RMR AND 6g Beta-Glucan (Viscofibre, Naturex SA, France) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40% |
| Control Non Beta glucan | No intervention | –10 days of weight loss diet calculated 100% RMR using a heterogeneous natural fibre for food ingredients, 30% protein, 30% fat, 40% CHO. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females
- 18-65 years old
- Body Mass Index (BMI) 27-42kg/m2
- Overall healthy
- Weight Stable (<3 kg change in the past 4 months, before the trial).
Key exclusion criteria (15 listed)
- Medical:
- Heavy smokers (more than 10 cigarettes/day) or heavy alcohol consumers (more than 4 alcohol units/day for male and more than 3 alcohol units/day for female).
- Obesity of endocrine origin.
- Chronic metabolic conditions: diabetes, hepatic disease, gout, kidney, thyroid or coagulation disease.
- Gastrointestinal disorders: celiac disease, Intenstinal Bowel Disease (IBD), irritable bowel syndrome (IBS), chronic constipation, diverticulitis, history of gastric bezoar. Suspected strictures, fistulas, or physiological GI obstruction.
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 |
|---|---|---|
| ArabinoxylanAlso: MC- NAXUS10 days of weight loss diet calculated as 100% RMR + 15g Arabinoxylan (Medium Chain Naxus, BioActor b.v., Netherlands) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40% carbohydrate. | Other | Arabinoxylan |
| Beta- GlucanAlso: Viscofiber10 days of weight loss diet calculated as 100% RMR + 6g β-glucan (Viscofibre, Naturex SA, France) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40% | Other | Beta-Glucan |
Primary outcome
Effect of Arabinoxylan or Beta- Glucan on weight loss and body composition
Time frame: 72 hours
During this part of the study the effect of novel fibre of 3 dietary interventions subsequent each other: Maintenance (3 days), Arabinoxylan or Beta glucan per 10 days and Control diet per 10 days. Weight loss will be assessed after dietary intervention. Changes on body weight, BMI and total and regional body composition information using a two compartment model (fat mass and fat free mass by air displacement densitometry -Bod-Pod) will be assessed at the end of each dietary intervention. Resting Metabolic Rate will be assessed the beginning and at the end of the weight loss diet (Deltatrac).
1 secondary outcome
Effect of Arabinoxylan or Beta- Glucan on gut health
Time frame: 23 days
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 4 May 2017.
- SATIN-EU Consortium web pageLink provided by the sponsor.
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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.
Dr Alexandra M Johnstone, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arabinoxylan and Beta- Glucan in people with Overweight and Obesity, 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 5 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 4 May 2017. 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?
Effect of Arabinoxylan or Beta- Glucan on weight loss and body composition (time frame: 72 hours). 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 4 May 2017.