SATIN: Satiety Innovation. Study 2- University of Aberdeen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Satiety Innovation- Study 793. University of Aberdeen

NCT01724411

Overweight and Obesity

COMPLETED NA

Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety

NCT03648112

Lipid Metabolism Glucose Metabolism Satiety

COMPLETED NA

The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects

NCT02796989

Healthy Obese

COMPLETED PHASE1/PHASE2

Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal

NCT04788069

Energy Intake Appetite Regulation

COMPLETED NA

Effectiveness of Sacha Inchi Supplementation on Postprandial Inflammation

NCT02886169

Cardiovascular Diseases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arabinoxylan

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

Group Type EXPERIMENTAL

Arabinoxylan

Intervention Type OTHER

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.

Control- Non Arabinoxylan

10 days of weight loss diet calculated 100% RMR using a heterogeneous natural fibre for food ingredients, 30% protein, 30% fat, 40% CHO.

Group Type NO_INTERVENTION

No interventions assigned to this group

Beta-Glucan

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%

Group Type EXPERIMENTAL

Beta- Glucan

Intervention Type OTHER

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%

Control Non Beta glucan

10 days of weight loss diet calculated 100% RMR using a heterogeneous natural fibre for food ingredients, 30% protein, 30% fat, 40% CHO.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arabinoxylan

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.

Intervention Type OTHER

Beta- Glucan

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%

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MC- NAXUS Viscofiber

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).

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, 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.
* Gastrointestinal procedure or surgery in the past three months.
* Disorders of swallowing, severe dysphagia to food or pills.
* Pregnancy

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes