NCT02604316

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 4, 2017

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

March 26, 2015

Last Update Submit

May 3, 2017

Conditions

Overweight and Obesity

Keywords

Overweight and ObesityAppetiteGut hormones and obesityArabinoxylan, Beta-GlucanSmartPill

Outcome Measures

Primary Outcomes (1)

  • 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).

    72 hours

Secondary Outcomes (1)

  • Effect of Arabinoxylan or Beta- Glucan on gut health

    23 days

Study Arms (4)

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

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%

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.

Interventions

ArabinoxylanOTHER

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.

Also known as: MC- NAXUS
Arabinoxylan
Beta- GlucanOTHER

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%

Also known as: Viscofiber
Beta-Glucan

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females
  • years old
  • Body Mass Index (BMI) 27-42kg/m2
  • Overall healthy
  • Weight Stable (\<3 kg change in the past 4 months, before the trial).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowett Institute of Nutrition and Health. University of Aberdeen

Aberdeen, AB219SB, United Kingdom

Location

Related Links

MeSH Terms

Conditions

OverweightObesity

Interventions

arabinoxylanbeta-Glucans

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydrates

Study Officials

  • Dr Alexandra M Johnstone, PhD

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2015

First Posted

November 13, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 4, 2017

Record last verified: 2016-09

Locations

GB(1)