Overweight and ObesitySATINNCT01724411
Satiety Innovation- Study 793. University of Aberdeen
A study testing Resistant Starch type 3 in people with Overweight and Obesity, run by P Burns 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?
- Resistant Starch type 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Dec 2014
- 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) 27-35kg/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, ulcerative colitis, irritable bowel syndrome (IBS), Chron's disease, 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 1
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 we 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 volunteers 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 (Nillson et al., 2008, Parnell \& Weimer, 2009, Willis et al 2009). Apparently, the large intestine microbiota recovers 'extra' calories from the diet and might contributes to obesity (Ley et al., 2006, Turnbaugh et al., 2008, Cani et al., 2007). However, the different mechanisms involved in lean and obese subjects are not completely resolved (Duncan et al., 2008, Schwiertz et al., 2010). Recent evidence in experimental animal designs indicates that changes in gut microbiota composition may be associated with increased food intake and obesity (Vijay-Kumar et al., 2010) suggesting that satiety and intake are influenced by the species composition of the gut microbiota.
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 we will address 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 volunteers in free living conditions. This study is part of the major European project launched in early 2011: SATIN, a collaborative, large-scale project that brings together the expertise of 18 participants across Europe to develop food products through novel food process that enhance satiety.
This short-term human nutrition study comprises in a cross-over design testing either a potentially satiety product, resistant starch type 3 (RS3) or an equivalent amount heterogeneous natural fibre in 24 healthy- obese volunteers, aged 18-65 years old, Body Mass Index (BMI) between 27 and 35kg/m2 from both genders after an initial 21 day weight-loss programme, 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. Gut transit will be monitored in six volunteers using a wireless motility device (SmartPill™)
- Conditions
- Overweight and Obesity
- Being tested
- Resistant Starch type 3
- Keywords
- Overweight and Obesity, Appetite, Gut hormones and obesity, Resistant Starch, Gut microbiota and obesity, 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.
Resistant Starch type 3Other
Also called C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium.
Resistant Starch 3: 26g/day males for 11 days, 22 g/day females for 11 days
| Study group | Role | What they receive |
|---|---|---|
| Resistant Starch 3 | Experimental | Resistant Starch Type 3:dose of 26g/day males and 22g/day female during 11 days of the maintenance period. (C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium) Receives: Other: Resistant Starch type 3 |
| Control Non- RS3 | No intervention | Non-Resistant Starch type 3 food items during 11 days of the maintenance period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of RS on weight loss
During this part of the study the effect of novel fibre (RS3)on weight loss will be assessed after dietary intervention. This will consist of a weight loss plan (21 days) and two maintenance periods (11 days) either with RS3 or no.
Changes in 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: 52 days
Secondary outcomes (2)
Effect of RS on gut health
The effect of a novel RS3 on gut health: Gut microbiota, short chain fatty acids production, and gut transit will be assessed.
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 six 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: 52 days
Effect of RS on gut hormones
Analysis of glucose, insulin, lipid profile and gut peptide will be performed. during the meal test challenge at the end of each dietary intervention (4 times). This will include analysis of Peptide YY (PYY336), Cholecystokinin (CCK), Glucagon-like peptide 1 (GLP1), Ghrelin, and Amylin at 0,30,60,90,120 and 180 minutes.
Measured: 52 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- P Burns
- 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-investigator, P Burns, University of Aberdeen
- Investigators
- Dr Alexandra M Johnstone, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724411
- Sponsor's protocol ID
- 2/040/12
- Other IDs
- 289800, 2012RW002
- Acronym
- SATIN
- Status last verified
- Mar 2015
- First submitted
- 24 Oct 2012
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnstone AM, Kelly J, Ryan S, Romero-Gonzalez R, McKinnon H, Fyfe C, Naslund E, Lopez-Nicolas R, Bosscher D, Bonnema A, Frontela-Saseta C, Ros-Berruezo G, Horgan G, Ze X, Harrold J, Halford J, Gratz SW, Duncan SH, Shirazi-Beechey S, Flint HJ. Nondigestible Carbohydrates Affect Metabolic Health and Gut Microbiota in Overweight Adults after Weight Loss. J Nutr. 2020 Jul 1;150(7):1859-1870. doi: 10.1093/jn/nxaa124.
PubMed 32510158
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SATIN: Satiety Innovation, Study 1
- ClinicalTrials.gov ID
- NCT01724411
- Acronym / sponsor ID
- SATIN / 2/040/12
- Conditions
- Overweight and Obesity
- Keywords
- Overweight and Obesity, Appetite, Gut hormones and obesity, Resistant Starch, Gut microbiota and obesity, SmartPill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- P BurnsUniversity, 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
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Nov 2012 (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 we 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 volunteers 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 (Nillson et al., 2008, Parnell \& Weimer, 2009, Willis et al 2009). Apparently, the large intestine microbiota recovers 'extra' calories from the diet and might contributes to obesity (Ley et al., 2006, Turnbaugh et al., 2008, Cani et al., 2007). However, the different mechanisms involved in lean and obese subjects are not completely resolved (Duncan et al., 2008, Schwiertz et al., 2010). Recent evidence in experimental animal designs indicates that changes in gut microbiota composition may be associated with increased food intake and obesity (Vijay-Kumar et al., 2010) suggesting that satiety and intake are influenced by the species composition of the gut microbiota.
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 we will address 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 volunteers in free living conditions. This study is part of the major European project launched in early 2011: SATIN, a collaborative, large-scale project that brings together the expertise of 18 participants across Europe to develop food products through novel food process that enhance satiety.
This short-term human nutrition study comprises in a cross-over design testing either a potentially satiety product, resistant starch type 3 (RS3) or an equivalent amount heterogeneous natural fibre in 24 healthy- obese volunteers, aged 18-65 years old, Body Mass Index (BMI) between 27 and 35kg/m2 from both genders after an initial 21 day weight-loss programme, 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. Gut transit will be monitored in six volunteers using a wireless motility device (SmartPill™)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant Starch 3 | Experimental | Other: Resistant Starch type 3Resistant Starch Type 3:dose of 26g/day males and 22g/day female during 11 days of the maintenance period. (C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium) |
| Control Non- RS3 | No intervention | –Non-Resistant Starch type 3 food items during 11 days of the maintenance period. |
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) 27-35kg/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, ulcerative colitis, irritable bowel syndrome (IBS), Chron's disease, 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 |
|---|---|---|
| Resistant Starch type 3Also: C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium.Resistant Starch 3: 26g/day males for 11 days, 22 g/day females for 11 days | Other | Resistant Starch 3 |
Primary outcome
Effect of RS on weight loss
Time frame: 52 days
During this part of the study the effect of novel fibre (RS3)on weight loss will be assessed after dietary intervention. This will consist of a weight loss plan (21 days) and two maintenance periods (11 days) either with RS3 or no. Changes in 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).
2 secondary outcomes
Effect of RS on gut health
Time frame: 52 days
Effect of RS on gut hormones
Time frame: 52 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 31 Mar 2015.
- Derived from this study: PubMed 32510158Johnstone AM, Kelly J, Ryan S, Romero-Gonzalez R, McKinnon H, Fyfe C, Naslund E, Lopez-Nicolas R, Bosscher D, Bonnema A, Frontela-Saseta C, Ros-Berruezo G, Horgan G, Ze X, Harrold J, Halford J, Gratz SW, Duncan SH, Shirazi-Beechey S, Flint HJ. Nondigestible Carbohydrates Affect Metabolic Health and Gut Microbiota in Overweight Adults after Weight Loss. J Nutr. 2020 Jul 1;150(7):1859-1870. doi: 10.1093/jn/nxaa124.
- SATIN-EU Consortium web pageLink provided by the sponsor.
- Rowett Institute of Nutrition and HealthLink provided by the sponsor.
- The University of AberdeenLink 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 Resistant Starch type 3 in people with Overweight and Obesity, run by P Burns 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 31 Mar 2015. 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 RS on weight loss (time frame: 52 days). 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 NCT01724411, which also lists 1 linked publication.
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 31 Mar 2015.