Investigating the effect of Plantago psyllium fiber supplementation on levels of cholesterol and inflammation in adolescents with obesity
| ISRCTN | ISRCTN14180431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14180431 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CIBIUG-P40-2017 |
| Sponsors | Mexican Social Security Institute, Universidad de Guanajuato |
| Funders | Universidad de Guanajuato, Touro University California, Mining Company Santa María de la Paz |
- Submission date
- 17/08/2020
- Registration date
- 24/08/2020
- Last edited
- 19/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Obesity can lead children and adolescents to have an increased risk of developing cardiovascular disease (CVD). A diet supplemented with Plantago psyllium (a type of fiber from the Plantago ovata plant's seeds) has been shown to be effective in reducing certain markers of blood cholesterol and inflammation in adolescents. However, there are no studies that have explored small-dense low-density lipoprotein (sdLDL) nor high-density lipoprotein (HDL) subclasses of cholesterol. The aim of this trial is to assess the impact of a fiber supplement on cholesterol in adolescents with obesity.
Who can participate?
100 adolescents, aged 15 to 19 years old, with obesity will be included in the study.
What does the study involve?
Eligible participants will be randomly allocated to recieve either the Plantago psyllium supplement or an identical dummy pill. These will be taken, dissolved in water, daily over a period of 7 weeks in the morning before food.
What are the possible benefits and risks of participating?
The benefits are the performance of free laboratory tests such as glucose, lipid profile such as cholesterol, triglycerides, insulin and lipoprotein profile with the sub-fractions of HDL and LDL (sdLDL), together with a clinical medical evaluation, which will contribute to the prevention of possible diseases and suggestion of healthy dietary recommendations.
The risks and discomfort that the patient may have are allergy or intolerance to the treatment, an increase in the number of evacuations, and abdominal distension. These side effects would be corrected when the treatment is suspended. Participants or their family members will be advised to suspend treatment if they experience any of these symptoms, and the trial team will determine if any further specific management for the symptoms is needed.
Taking the blood sample involves only the risk of a bruise, which will take between one and two weeks to disappear from the puncture site.
Where is the study run from?
Universidad de Guanajuato (Mexico)
When is the study starting and how long is it expected to run for?
From February 2017 to March 2020
Who is funding the study?
The University of Guanajuato (Mexico) and Touro University (USA)
Who is the main contact?
Patricia González
patipili999@gmail.com
+52 477 132 91 26
Contact information
Public
UMAE no 48 IMSS Hospital
Avenida México e Insurgentes S/N colonia Los paraísos
Leon
37238
Mexico
 ORCID ID |
0000-0002-3401-7519 |
|---|---|
| Phone | +52 477 717 48 00 ext 31804 |
| patipili999@gmail.com |
Public
UMAE no 48 IMSS Hospital
Avenida México e Insurgentes S/N colonia Los paraísos
Leon
37328
Mexico
| ORCID ID |
0000-0002-8460-4965 |
|---|---|
| Phone | +52 477 3931426 |
| patriciasosab@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre, double-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Reduction of small dense LDL and Il-6 after intervention with Plantago psyllium in adolescents with obesity |
| Study acronym | sdLDLpsyllium |
| Study objectives | Supplementation with Plantago psyllium alone decreases the concentration of sdLDL and inflammation markers (IL-6) in the population at risk such as adolescents with obesity |
| Ethics approval(s) | 1. Approved 03/08/2018, University of Guanajuato (Calzada de Guadalupe S/N, Zona centro, Guanajuato Gto., México CP 36000; +52 473 73 200 06 ext. 5019); ref: CIBIUG-P40-2017 2. Approved 26/10/2018, Hospital de Gineco-pediatría No. 48 (Av. México e Insurgentes S/N colonia Los insurgentes, León Gto., México CP 37238; +52 477 7-17-48-00), ref: R-2018-1002-052 |
| Health condition(s) or problem(s) studied | Cardiovascular disease in adolescents with obesity |
| Intervention | This study was a randomized placebo-controlled trial with a double-blinded (to the participant and the investigator who gave the treatment) design. Randomization and allocation to trial group were done using computer random number generation. All participants were randomized into a 7 week intervention with either 10 g/day of psyllium (equating to 10 g of dietary fiber) Plantago psyllium powder (Kirkland signature ®, Lot 0294B12), or 10 g/day of rice flour placebo (Healthy Flours ® batch AB140119). In both groups, the dose was diluted in 250 ml of water, ingested immediately after dilution with intake of 250 ml of additional water, in the morning, before ingesting food. The dose of 10 g/day was adopted based on a review of the existing literature, as well as on the volume of fiber and placebo each dose would equate to, so as not to affect compliance with the study protocol. Both the psyllium and rice flour were packed in opaque bags without labeling the name only as A or B. Each dose was given daily by the blinded investigator. Adherence to dosing was monitored directly through a checklist and during the weekend through a photograph sent by the participant through What’sApp. Participants were advised to continue their normal eating and exercise patterns during the study period. Three dietary records were collected at baseline and at clinical assessment following the 7 week intervention. Each dietary report encompassed an itemized nutritional intake recorded during two school days and one weekend day. Nutritional intake was recorded using standard household measures, as well as the information from food labels where appropriate. At each visit during the dietary treatment phase, the participants were asked about possible adverse effects or intolerance to psyllium or placebo using an open-ended questionnaire referring to any unusual symptoms or discomfort or side effects such as increased defecation, bloating, flatulence or fullness during the treatment period. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
1. Anthropometric and biochemical markers measured using the following at baseline and 7 weeks: |
| Key secondary outcome measure(s) |
Somatometric variables measured using the following at baseline and 7 weeks: |
| Completion date | 02/03/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 15 Years |
| Upper age limit | 19 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 15 to 19 years 2. ≥1 of the following cardiovascular risk factors: 2.1. Obesity, defined as a body mass index (BMI) for age more than 2 standard deviations above the median established in the World Health Organization (WHO) Child Growth Standards 2.2. Altered lipid profile, defined as: total cholesterol >70 mg/dl; LDL cholesterol >110 mg/dl; HDL cholesterol <40 mg/dl; fasting glucose >100 mg/dl; elevated triglycerides >90 mg/dl; or insulin resistance with Homeostatic Model Assessment of Insulin Resistance (HOMA IR) >3 3. Non-smokers |
| Key exclusion criteria | 1. Do not agree to adhere to at least 80% of diet and fiber 2. Diagnosis of a metabolic and/or infectious disease during the study 3. Do not wish to continue in the study or unable to be located for follow up |
| Date of first enrolment | 10/11/2018 |
| Date of final enrolment | 15/12/2019 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Obregon
Leon, Guanajuato
37000
Mexico
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | Data sets generated and/or analyzed during the current study during this study will be included in the publication of subsequent results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/08/2021 | 19/04/2021 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/04/2021: Publication reference and total final enrolment added.
24/08/2020: Trial’s existence confirmed by the University of Guanajuato.
