NCT03322514

Brief Summary

The current protocol aims to investigate the impact of the propionate ester in conjugation with restricted diet on appetite and weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 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

March 29, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 7, 2019

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

May 10, 2017

Results QC Date

October 16, 2019

Last Update Submit

November 11, 2019

Conditions

Healthy Obesity, MetabolicallyAppetite Regulation

Keywords

gut hormonesobesityappetitepropionatefermentation

Outcome Measures

Primary Outcomes (1)

  • Change in Weight Loss Compared to Baseline

    The weight assessed by a body scale

    Baseline and 12 weeks

Secondary Outcomes (2)

  • Glucose Blood Level Baseline to 12 Weeks

    Baseline, 12 weeks

  • Insulin Level in Serum

    Baseline, 12 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

10 g of Inulin-Propionate Esters will be administered per day

Dietary Supplement: Inulin-Propionate Esters

Inulin

ACTIVE COMPARATOR

10 g of Inulin will be administered per day

Dietary Supplement: Inulin

Interventions

Inulin-Propionate EstersDIETARY_SUPPLEMENT

Inulin (β(2-1) linked polymer of fructose) carrier with an ester linked to propionate (propionate ester). Thus, propionate is only released when the carrier molecule inulin is fermented by colon microflora.

experimental group
InulinDIETARY_SUPPLEMENT

Inulin

Inulin

Eligibility Criteria

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

You may qualify if:

  • overweight or obese ((BMI) of 25-35 kg/m2)
  • healthy
  • aged between 18 and 65 years

You may not qualify if:

  • Weight change of ≥ 3kg in the preceding 2 months
  • Undergone any weight loss surgery or gastric procedures to promote weight loss
  • Current smokers
  • Substance abuse
  • Excess alcohol intake
  • Pregnancy
  • Diabetes
  • Cardiovascular disease
  • Cancer
  • Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
  • Kidney disease
  • Liver disease
  • Pancreatitis
  • Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
  • Any participants with the above conditions would already have an altered pattern of hormones and inflammatory molecules because of their disease process and would therefore give us confounding or misleading results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR/Wellcome Trust Imperial Clinicial Research Facility

London, W12 0NN, United Kingdom

Location

Related Publications (1)

  • M. Khatib, E. Chambers, D. Morrison and G. Frost. A pilot study to evaluate the effect of increased colonic propionate on appetite during a hypocaloric diet. Proceedings of the Nutrition Society (2018), 77 (OCE4), E119.

    RESULT

MeSH Terms

Conditions

Obesity, Metabolically BenignObesity

Interventions

Inulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Results Point of Contact

Title
Prof Gary Frost
Organization
Imperial College London
g.frost@imperial.ac.uk
+44 (0)20 7594 0959

Study Officials

  • Gary Frost

    Dietitian; PhD in Nutrition; Professor of nutrition and dietetics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: double blind, randomised, controlled, paralleled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2017

First Posted

October 26, 2017

Study Start

March 29, 2017

Primary Completion

November 11, 2017

Study Completion

November 11, 2017

Last Updated

November 20, 2019

Results First Posted

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)