NCT01724411

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

October 24, 2012

Last Update Submit

March 26, 2015

Conditions

Overweight and Obesity

Keywords

Overweight and ObesityAppetiteGut hormones and obesityResistant StarchGut microbiota and obesitySmartPill

Outcome Measures

Primary Outcomes (1)

  • 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).

    52 days

Secondary Outcomes (2)

  • Effect of RS on gut health

    52 days

  • Effect of RS on gut hormones

    52 days

Other Outcomes (1)

  • Effect of RS on Appetite subjective sensations

    52 days

Study Arms (2)

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)

Other: Resistant Starch type 3

Control Non- RS3

NO INTERVENTION

Non-Resistant Starch type 3 food items during 11 days of the maintenance period.

Interventions

Resistant Starch type 3OTHER

Resistant Starch 3: 26g/day males for 11 days, 22 g/day females for 11 days

Also known as: C ActiStar 11700, Tapioca Maltodextrin, Cargill, Belgium.
Resistant Starch 3

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) 27-35kg/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, 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
  • 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 Publications (1)

  • 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.

    PMID: 32510158DERIVED

Related Links

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Governance Manager R&D University of Aberdeen, NHS Grampian

Study Record Dates

First Submitted

October 24, 2012

First Posted

November 9, 2012

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2014

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

GB(1)