Satiety Innovation- Study 793. University of Aberdeen (SATIN)

This study is currently recruiting participants.
Verified November 2012 by University of Aberdeen
Sponsor:
Collaborators:
Kobenhavens Universitaet, Denmark
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., Spain
Naturex, Spain
Axxam S.p.A., Italy
BioActor
Asociación Empresarial de Investigación Centro Tecnológico Nacional Agroalimentario, “Extremadura”, Spain
Centro Tecnológico Nacional de la Conserva y Alimentación, Spain
NIZO Food Research
RTD Services Vienna, Austria
ProDigest BVBA, Belgium
Information provided by (Responsible Party):
Dr Gail Holland, University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01724411
First received: October 24, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Overweight and Obesity
Other: Resistant Starch type 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: SATIN: Satiety Innovation. Study 1

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Effect of RS on weight loss [ Time Frame: 52 days ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Effect of RS on gut health [ Time Frame: 52 days ] [ Designated as safety issue: No ]

    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.


  • Effect of RS on gut hormones [ Time Frame: 52 days ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Effect of RS on Appetite subjective sensations [ Time Frame: 52 days ] [ Designated as safety issue: No ]
    A 4-questions and 100mm, Visual Analogue Scale (VAS) will be used to measure motivation to eat and appetite e.g. asking questions about hunger, desire to eat, fullness and prospective consumption every hour during awakening hours during 3 days of each phase of the dietary intervention.


Estimated Enrollment: 24
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistant Starch Type 3
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)
Other: Resistant Starch type 3
26g/day males for 11 days 22 g/day females for 11 days
Other Name: (C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium)
No Intervention: Non- Resistant Starch Type 3
Non-Resistant Starch type 3 food items during 11 days of the maintenance period.

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™)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724411

Contacts
Contact: Dr Reyna P Romero-Gonzalez, MSc Nutrition 00441224438582 ext 8582 r.romerogonzalez@abdn.ac.uk
Contact: Dr Alexandra M Johnstone, PhD. 00441224438614 ext 8614 alex.johnstone@abdn.ac.uk

Locations
United Kingdom
Rowett Institute of Nutrition and Health. University of Aberdeen Recruiting
Aberdeen, United Kingdom, AB219SB
Contact: Dr. Reyna Romero-Gonzalez, Physician&Surgeon    00441224438586 ext 8586    r.romerogonzalez@abdn.ac.uk   
Contact: Dr Alexandra M Johnstone, PhD    00441224438614 ext 8614    alex.johnstone@abdn.ac.uk   
Principal Investigator: Dr Alexandra M Johnstone, PhD. Research Fellow         
Sub-Investigator: Harry Flint, Professor         
Sub-Investigator: Sylvia Dunca, PhD         
Sub-Investigator: Gratz Silvia, PhD         
Sub-Investigator: Reyna P Romero-Gonzalez, Physician&Surgeon         
Sub-Investigator: Ilaria Pesci, PhD Student         
Sponsors and Collaborators
Dr Gail Holland
Kobenhavens Universitaet, Denmark
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., Spain
Naturex, Spain
Axxam S.p.A., Italy
BioActor
Asociación Empresarial de Investigación Centro Tecnológico Nacional Agroalimentario, “Extremadura”, Spain
Centro Tecnológico Nacional de la Conserva y Alimentación, Spain
NIZO Food Research
RTD Services Vienna, Austria
ProDigest BVBA, Belgium
Investigators
Principal Investigator: Dr Alexandra M Johnstone, PhD University of Aberdeen
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Gail Holland, Research Governance Manager R&D University of Aberdeen, NHS Grampian, University of Aberdeen
ClinicalTrials.gov Identifier: NCT01724411     History of Changes
Other Study ID Numbers: 2/040/12, 289800, 2012RW002
Study First Received: October 24, 2012
Last Updated: November 6, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
Overweight and Obesity
Appetite
Gut hormones and obesity
Resistant Starch
Gut microbiota and obesity
SmartPill

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014