Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/02/2019
Date assigned
06/02/2019
Last edited
06/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Overweight and obesity affects over 60% of the UK population. In adults, most weight gain occurs when people are in their 20s and 30s and causes many adults to become obese by the time they are middle-aged, leading to increased risk of developing diabetes, heart disease and cancer. There is increasing evidence that diet plays an important role in preventing obesity. The amount of fibre (found in edible plant foods such as cereals, fruits, vegetables, dried peas, nuts, lentils and grains) eaten in the diet has been linked to body weight. People who eat low amounts of dietary fibre are more likely to gain weight. Dietary fibre is the major food for the bacteria that live in our gut. It is known that dietary fibre keeps the bacteria in the gut healthy. These bacteria break down dietary fibre to short chain fatty acids (smaller pieces of fibre) which can reduce appetite and body fat. One short chain fatty acid called Propionate appears to be the most powerful at reducing appetite. Propionate by itself would be broken down rapidly in the body so a new food supplement has been created called Inulin Propionate Ester (IPE) which is Propionate chemically bound to a fibre called Inulin. Inulin is a type of fibre normally found in garlic, Jerusalem artichoke, chicory and onion. The IPE simply delivers the Propionate to the right region of the gut where it is thought to be most effective. The aim of this study is to investigate the effects of IPE as a dietary supplement, on prevention of weight gain in young adults aged 20-35 years at high risk of gaining weight, across a period of 12 months.

Who can participate?
Adults aged between 20 to 35 years who have a Body Mass Index (BMI) of either 25-30kg/m2 if non-South Asian, or 24-27kg/m2 if of South Asian origin. BMI is a value calculated from height and weight, which estimates body fat. One or more of the following must also apply: having gained 2 kg or more over the past year, low level of physical activity, eating less than two portions a day of fruit and vegetables, or drinking more than one sugary drink per day. If taking any medication, this should be stable.

What does the study involve?
Participants complete a questionnaire and attend a screening visit where they are seen by a doctor and asked questions about their medical history, current health and any medications. Measurements of height, weight, waist and hip circumference, body composition are taken and BMI is calculated. They have a full blood test and all females of child bearing potential complete a pregnancy test. If shown to be anaemic, blood is tested for Vitamin B12 levels. A physical activity questionnaire is completed and lifestyle questions asked by the researcher. Participants are then asked to return for a second visit and complete a 7 day written food diary. At the second visit, participants have all procedures carried out during the screening visit repeated except for the full blood count and height. There is also a tracing of the electrical activity of their heart (ECG (electrocardiogram)) and measurement of blood pressure. Participants have a fasting blood test to measure glucose and their lipid profile and a blood test to measure Insulin. The questionnaire regarding physical activity is repeated and lifestyle questions asked. Participants are randomly allocated to either IPE or Inulin for 12 months. 2 months’ worth of sachets are dispensed, enough until the participant returns for their next study visit. They are asked to take one sachet daily before/after/with food or drink. Participants are asked to return for a 2 month study visit. Once again they are asked to complete a 7-day written food diary and bring back all their used/unused sachets. At the 2 month visit, participants are asked for updates in regards to medical history, health, any medications and if they have had any adverse events. Measurements of weight, waist and hip circumference, body composition are taken, BMI calculated, and they have their blood pressure measured. All females complete a pregnancy test. The questionnaire regarding physical activity is completed and updates on lifestyle asked. They do not need to provide a blood sample at this visit. The 7 day food diary is collected. Sachet returns are collected from the participant and counted for accountability and compliance. They are provided with 4 more months’ worth of sachets, to last until the 6 month study visit. Participants are asked to return for a 6 month study visit. Again they are asked to complete a 7 day written food diary. At the 6 month visit, all procedures and measurements taken at the 2 month visit are repeated and this time a fasting blood test (10 ml) is done to measure glucose and their lipid profile and a blood test (4 ml) done to measure Insulin. A 6 month supply of supplement sachets is dispensed, to last until the 12 month study visit. Participants are asked to complete a 7 day written food diary one final time. At the 12 month (final) study visit, all procedures and measurements taken at the 6 month visit are repeated a final time, but no further supplement sachets are dispensed and the food diary is collected from the participant. Participants are not paid for the eligibility/screening visit but are paid £50 for attending each study visit thereafter and reasonable travel expenses are reimbursed.

What are the possible benefits and risks of participating?
Participants may not benefit directly from this study but the results may help doctors in the future treat people who are overweight and at risk of gaining weight, in preventing weight gain. Participants may find that the IPE supplement helps prevent gain weight, however these effects may only be short lived and at the present time the IPE supplement is not commercially available. Most of the procedures in this study, such as the recording of your weight, height, hip, waist, body composition and blood pressure present no risk. Other procedures, such as taking blood samples, can cause mild discomfort. The risks of taking a blood sample include: slight discomfort when the needle is inserted and possible bruising or a localised infection. These procedures will only be carried out by an experienced health professional under sterile conditions to minimise all these risks. There are no major side effects associated with taking the IPE supplement. Some participants may find the taste unpleasant (slightly metallic) or may experience mild nausea, abdominal bloating or other gut symptoms initially, however these should settle down after a few days.

Where is the study run from?
This study is being organised by doctors and scientists at Imperial College London and is being run across two clinical research facilities - one in London, part of Imperial College Healthcare NHS Trust, and one in Glasgow, part of NHS Research Scotland.

When is the study starting and how long is it expected to run for?
March 2018 to August 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Aisha Anjum
a.anjum@imperial.ac.uk / iPREVENT@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Aisha Anjum

ORCID ID

Contact details

Imperial Clinical Trials Unit
Imperial College London
1st Floor
Stadium House
68 Wood Lane
London
W12 7RH
United Kingdom
+44 (0)207 594 1723
a.anjum@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

38959

Study information

Scientific title

Increase in colonic PRopionate as a method of prEVENTing weight gain in young adults

Acronym

iPREVENT

Study hypothesis

Inulin Propionate Ester (IPE) supplementation will prevent weight gain compared with inulin control in young adults at higher risk of weight gain

Ethics approval

London Hampstead REC, HRA Office: Barlow House, 3rd Floor, 4 Minshull Street, Manchester M1 3DZ, Tel: +44 (0)207 104 8127, +44 (0)207 104 8345, Email: NRESCommittee.London-Hampstead@nhs.net, 24/01/2019, ref: 19/LO/0095

Study design

Randomised; Interventional; Design type: Prevention, Dietary

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Obesity and other hyperalimentation

Intervention

Method of randomisation: minimisation

Either IPE or a control dietary fibre will be given to 270 volunteers in 10g sachets and they will be asked to take one sachet per day with their normal diet for 12 months. The volunteers will attend study visits at 2, 6 and 12 months.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Weight gain (clinic measured weight) from baseline to 12 months

Secondary outcome measures

1. Occurrence of Adverse Events and Serious Adverse Events (self reported and asked during study visits) over the duration of the study
2. Changes in fasting biochemistry (blood results of samples taken during study visits) from baseline to 6 and 12 months:
2.1. Glucose
2.2. Insulin
2.3. Triglycerides
2.4. Total cholesterol
2.5. Low Density Lipoprotein (LDL) cholesterol
2.6. High Density Lipoprotein (HDL) cholesterol
3. Changes in blood pressure (clinic measured BP) from baseline to 2, 6 and 12 months
4. Changes in body weight (clinic measured weight) from baseline to 2 and 6 months
5. Changes in waist/hip/BMI/body composition measurements - Fat Mass (FM), Fat Mass Index (FMI), percent body fat (Fat%), fat free body mass, (FFM) and FM/FFM ratio (clinic measurements and clinic measured bioelectrical impedance) from baseline to 2, 6 and 12 months
6. Changes in appetite (7-day food diary completion) from baseline, to 2, 6 and 12 months
7. Changes in compliance (returned used/unused sachets count) from baseline to 2, 6 and 12 months
8. Changes in diet (7-day food diary completion) from baseline, to 2, 6 and 12 months

Overall trial start date

01/03/2018

Overall trial end date

31/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Males and females aged 20-35 years
2. BMI of 24-27kg/m2 if of South Asian ethnicity or 25-30kg/m2 if non-South Asian, and at least one of the following:
2.1. A self-reported weight gain of 2kg or more over the last 12 months
2.2. Low self-reported physical activity (‘inactive’ or ‘minimally active’ as per IPAQ)
2.3. Low self-reported fruit and vegetable intake (< 2 servings of fruit and vegetables per day)
2.4. Self-reported high intake of sugar sweetened beverages (> 1 serving per day)
3. On stable medication (if taking any) at point of screening
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 270; UK Sample Size: 270

Participant exclusion criteria

1. Diagnosed chronic disease; Type I and II diabetes, cancer, renal failure, heart disease, organic acidaemia (propionic acidaemia, methyl malonic acidaemia)
2. Diagnosed gastrointestinal condition including coeliac disease, inflammatory bowel disease and irritable bowel syndrome
3. Previous bowel reconstruction surgery
4. Pregnancy or lactation
5. Use of antibiotics at any time in the past 3 months
6. Anaemic AND Vitamin B12 deficient (< 160 ng/L)
7. Taking part in a weight loss program or consuming a weight loss product
8. Have lost 3kg or more in the last 3 months
9. Any other gastrointestinal upset (such as diarrhoea/constipation in the last 2 weeks, abdominal cramping etc)
10. Any other reason in the opinion of the investigator

Recruitment start date

01/03/2019

Recruitment end date

29/02/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial Clinical Research Facility
Imperial Centre for Translational and Experimental Medicine Imperial College Healthcare NHS Trust, Hammersmith Hospital Du Cane Road
London
W12 0HS
United Kingdom

Trial participating centre

Glasgow Clinical Research Facility
NHS Greater Glasgow & Clyde Glasgow Royal Infirmary New Lister Building 10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Sponsor information

Organisation

Imperial College of Science, Technology and Medicine

Sponsor details

c/o Ms Becky Ward
Joint Research Compliance Office
Imperial College Academic Health Science Centre
Room 215
Medical School Building
St Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 9459
becky.ward@imperial.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 15/185/16

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal, within one year of end of study.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes