Increasing Inulin Propionate Ester in the gut, for prevention of weight gain in adults aged 20-40 years at higher risk of weight gain.
| ISRCTN | ISRCTN16299902 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16299902 |
| IRAS number | 229300 |
| Secondary identifying numbers | CPMS 38959, IRAS 229300 |
- Submission date
- 04/02/2019
- Registration date
- 06/02/2019
- Last edited
- 08/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Overweight and obesity affect 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 an 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 into 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 the prevention of weight gain in young adults aged 20-40 years at high risk of gaining weight, across a period of 12 months.
Who can participate?
Adults aged between 20 to 40 years who have a Body Mass Index (BMI) of either 25-30 kg/m2 if non-South Asian, or 24-27 kg/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, and body composition are taken and BMI is calculated. They have a full blood test and all females of childbearing potential complete a pregnancy test. A physical activity questionnaire is completed and lifestyle questions are 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. Blood pressure will also be measured. 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 are 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 regard to medical history, health, any medications and if they have had any adverse events. Measurements of weight, waist and hip circumference, and body composition are taken, BMI is 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 are 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 lipid profile and a blood test (4 ml) is 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 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?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
March 2018 to November 2022
Who is funding the study?
National Institute for Health Research - Efficacy and Mechanism Evaluation Programme (NIHR-EME) (UK)
Who is the main contact?
Christina Prechtl, iPREVENT@imperial.ac.uk
Contact information
Scientific
Imperial Clinical Trials Unit, Imperial College London
1st Floor, Stadium House, 68 Wood Lane
London
W12 7RH
United Kingdom
| Phone | +44 (0)207 594 1723 |
|---|---|
| c.prechtl@imperial.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Prevention, Dietary |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Increase in colonic PRopionate as a method of prEVENTing weight gain in adults aged 20-40 years (iPREVENT) |
| Study acronym | iPREVENT |
| Study hypothesis | Current hypothesis as of 22/04/2021: Inulin Propionate Ester (IPE) supplementation will prevent weight gain compared with inulin control in adults age 20-40 years at higher risk of weight gain. _____ Previous 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(s) | 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 |
| Condition | Obesity and other hyperalimentation |
| Intervention | Current intervention as of 20/01/2022: Method of randomisation: minimisation Either IPE or a control dietary fibre will be given to 270 volunteers in 10 g 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. For sub study participants, the baseline and 12 month visits will be more extensive, with blood samples, breath samples, calorimetry measurements, urine sample, stool sample, appetite score taken and a test meal consumed. Previous 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 |
| Primary outcome measure | Weight gain (clinic measured weight) from baseline to 12 months |
| Secondary outcome measures | Current secondary outcome measures as of 20/01/2022: 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) during the 12 month intervention 9. Changes in physical activity during the 12 month intervention 10. Changes in other lifestyle factors during the 12 month intervention; smoking, drinking and recreational drugs Sub-study (exploratory/mechanistic): 1. To explore the effects of IPE on colonic metabolism using metataxonomic analysis of the 16S ribosomal ribonucleic acid (rRNA) gene in stool samples, to identify the relative abundance of the bacterial component of the microbiome. 2. To explore the effects of IPE on the metabolite profile using nuclear magnetic resonance spectroscopic analyses. These data will be used to determine how these specific changes in the colonic environment influence L-cell differentiation using a human organoid model. 3. To explore the effects of IPE on anorectic gut hormones (GLP-1, PYY, gastrin and CCK) and subjective feelings of appetite via visual analogue scales (VAS), as measures of appetite regulation. 4. To explore the effects of IPE on energy expenditure and hepatic lipid metabolism as potential mechanisms involved in body weight maintenance. Previous 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 study start date | 01/03/2018 |
| Overall study end date | 30/11/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 270; UK Sample Size: 270 |
| Total final enrolment | 270 |
| Participant inclusion criteria | Current inclusion criteria as of 22/04/2021: 1. Males and females aged 20-40 years 2. BMI of 24-27 kg/m2 if of South Asian ethnicity or 25-30 kg/m2 if non-South Asian, and at least one of the following: 2.1. A self-reported weight gain of 2 kg 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 _____ Previous 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 exclusion criteria | Current exclusion criteria as of 04/01/2022: 1. Diagnosed with 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. Untreated Vitamin B12 deficiency (<160 ng/l) 7. Taking part in a weight loss program or consuming a weight loss product 8. Have lost 3 kg 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 For sub-study: 1. Known anaemia or as per screening blood results (haemoglobin levels of <130 g/l for males and <110 g/l for females) 2. Allergies or intolerances to any of the ingredients in the set sub-study meals _____ Previous 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 | 25/07/2019 |
| Recruitment end date | 31/10/2021 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Imperial College Healthcare NHS Trust, Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Glasgow Royal Infirmary
New Lister Building
10 Alexandra Parade
Glasgow
G31 2ER
United Kingdom
Sponsor information
University/education
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
England
United Kingdom
| Phone | +44 (0)20 7594 9459 |
|---|---|
| becky.ward@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Current publication and dissemination plan as of 05/04/2023: Planned publication in a high-impact peer-reviewed journal, within one year of the end of the study. Planned dissemination events to take place for participants and the public, within 1-2 years of the end of the study. Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal, within 1 year of the end of the study. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 10/10/2022 | 05/04/2023 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Statistical Analysis Plan | version 2.0 | 18/03/2024 | No | No | |
| Results article | 25/09/2024 | 08/10/2024 | Yes | No |
Additional files
Editorial Notes
08/10/2024: Publication reference added.
01/05/2024: The intention to publish date has been changed from 01/05/2024 to 01/01/2025.
19/03/2024: The intention to publish date has been changed from 14/09/2023 to 01/05/2024.
18/03/2024: Statistical analysis plan added.
05/04/2023: The following changes have been made and the plain English summary updated accordingly:
1. IRAS number added.
2. The overall trial end date has been changed from 30/09/2022 to 30/11/2022.
3. The intention to publish date has been changed from 31/03/2023 to 14/09/2023.
4. The trial website has been removed.
5. The total final enrolment has been added.
6. The public contact was changed.
7. Publication reference added.
20/01/2022: The following changes have been made:
1. The intervention has been updated.
2. The secondary outcome measures have been updated.
04/01/2022: The following changes have been made:
1. The participant type has been changed from "Patient" to "Healthy volunteer".
2. The participant exclusion criteria have been changed to and the plain English summary updated accordingly.
22/04/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/03/2019 to 25/07/2019.
2. The recruitment end date has been changed from 29/02/2020 to 31/10/2021.
3. The overall trial end date has been changed from 31/08/2021 to 30/09/2022.
4. The intention to publish date has been changed from 31/08/2022 to 31/03/2023.
5. The public title has been changed from "Increasing Inulin Propionate Ester in the gut, for prevention of weight gain in young adults aged 20-35 years, at higher risk of weight gain" to "Increasing Inulin Propionate Ester in the gut for prevention of weight gain in adults aged 20-40 years at higher risk of weight gain.".
6. The scientific title has been changed from "Increase in colonic PRopionate as a method of prEVENTing weight gain in young adults" to "Increase in colonic PRopionate as a method of prEVENTing weight gain in adults aged 20-40 years (iPREVENT)".
7. The study hypothesis has been changed.
8. The trial website has been added.
9. The participant type has been changed from 'Patient' to 'Healthy volunteer'.
10. The participant inclusion criteria have been changed.
11. The plain English summary has been updated to reflect these changes.
