OverweightNCT01665742
Anti-inflammatory Dietary Intervention in Overweight and Obese Adolescents
A study testing Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene in people with Overweight and Obesity, run by University College Dublin at 3 sites in Ireland.
Trial summary
The number of overweight and obese children has increased in Ireland at a greater rate than worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase in the number of unhealthy inflammatory hormones and fats circulating in the blood which increase an adolescent's risk of developing… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesIreland
- Study dates
- Jan 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female
- 13-18 years
- Body mass index ≥ 91st percentile on UK growth reference charts (Cole, 1995)
- Medications/dietary supplements which do not interfere with the intervention are allowed, on condition that the participants adhere to the same regimen during the intervention, including oral contraceptives and other non-fatty acid based dietary supplements (e.g. garlic)
- Smoker or non-smoker
- Not participating in any other intervention study
Who cannot join
- Pregnancy or lactation
- Endocrine disorders such as Polycystic Ovary Syndrome
- Currently on treatment for a chronic inflammatory condition such as asthma
- Kidney or liver dysfunction
- Iron deficiency anaemia
- Prescribed anti-inflammatory medication
Show all 12Show fewer
- Consumers of fatty acid supplements including fish oils, evening primrose oil and antioxidant vitamin (A, C, E, -carotene) supplements
- High consumers of oily fish (> 2 servings/week)
- Participants planning to start a special diet or lose weight (e.g. Slimfast, Atkins etc)
- Weight change ≥3kg within the last 3 months
- Alcohol or drug abuse (based on clinical judgement)
- Participants with an allergy to fish and/or shellfish
Trial locations and contacts
3 sites in 1 country.
Ireland3 sites
Adelaide and Meath Hospital, Incorporating the National Children's Hospital Dublin,
Dublin
Trinity Centre for Health Sciences, St, James's Hospital
Dublin
University College Dublin
Dublin
About this study
Official title: Novel Anti-inflammatory Dietary Intervention to Improve the Metabolic Phenotype of Overweight and Obese 13-18 Year Old Adolescents - Insights Into Potential Genetic Susceptibility
The number of overweight and obese children has increased in Ireland at a greater rate than worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase in the number of unhealthy inflammatory hormones and fats circulating in the blood which increase an adolescent's risk of developing diabetes and heart disease later in life. Dietary patterns have changed whereby key nutrients that are found in fruit, vegetables and fish, which are known to have beneficial effects and reduce risk of obesity and diabetes in later life, may need to be replaced. This project will determine whether a key anti-inflammatory nutrient supplement taken for 8 weeks will improve the metabolic profile of adolescents aged 13-18 years old. Detailed cellular analysis will determine the cellular and molecular mechanisms to provide a thorough explanation of the health effects of this intervention.
Read the detailed description
The emerging model of obesity and diabetes is characterised by sub-acute chronic inflammation and insulin resistance. Mechanistic data indicates inflamed adipose tissue with increased infiltration of immune cells that generate pro-inflammatory cytokines. With childhood obesity in Ireland increasing at a rapid pace, it is important to establish the role of a non-pharmacological dietary approach to decreasing the sub-acute chronic inflammation seen in overweight and obese children. Several foods contain nutrients that are known to have anti-inflammatory properties. Such foods including fish, fruits and vegetables are known to be deplete in the adolescent diet. The aim of this project is to investigate whether a nutritional supplement containing anti-inflammatory nutrients, n-3 polyunsaturated fatty acids (found in fish oil), vitamin C, vitamin E, and polyphenols found in green tea and tomato; will improve metabolic phenotype in 13-18 year old teenagers over an 8-week period. Further, to provide insight into the role of genetics in the development of metabolic dysregulation and response to dietary treatment.
- Conditions
- Overweight, Obesity
- Being tested
- Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene, Placebo supplement
- Keywords
- Obesity, Chronic inflammation, Anti-inflammatory dietary intervention, Genetic susceptibility
- Medical subject headings
- Overweight, Obesity, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopeneDietary supplement
1 x fruit juice fortified with salmon oil containing 1000mg EPA and 1000mg DHA daily for 8 weeks
AND
4 x film-coated tablets containing 561mg vitamin C, 389mg alpha-tocopherol, 416mg green tea extract and 15mg lycopene daily for 8 weeks
in conjunction with a weight management programme
Placebo supplementDietary supplement
1 x fruit juice fortified fortified with high oleic sunflower oil daily for 8 weeks
AND
4 x film-coated placebo tablets daily for 8 weeks
in conjunction with a weight management programme
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory supplement | Active comparator | 8-weeks of daily supplementation with:
1 x fruit juice fortified with fish oil, and 4 x film-coated tablets containing vitamin C, alpha-tocopherol, green tea extract and lycopene
in conjunction with a weight management programme Receives: Dietary Supplement: Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene |
| Placebo supplement | Placebo comparator | 8 weeks of daily supplementation with:
1 x fruit juice fortified with high-oleic sunflower oil, and 4 x film-coated placebo tablets
in conjunction with a weight management programme Receives: Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostasis model of assessment - insulin resistance
Homeostasis model of assessment - insulin resistance (HOMA-IR) will be derived from fasting glucose and insulin concentrations [(fasting plasma glucose x fasting serum insulin)/22.5] as determined by Matthews et al., 1985
Measured: 8 weeks
Secondary outcomes (5)
Adiponectin
Adiponectin, a marker of insulin sensitivity, will be determined pre- and post-intervention.
Measured: 8 weeks
Markers of inflammation
Markers of inflammation such as C reactive protein, interleukin (IL) - 6, IL-1β, tumour necrosis factor alpha, intra-cellular adhesion molecule-1, vascular cell adhesion molecule-1, retinol binding protein 4, fibrinogen, white blood cells and related inflammatory markers
Measured: 8 weeks
Lipid Profile
Full lipid profile and lipidomic analyses (total triacylglycerol, non-esterified fatty acids, total cholesterol, LDL cholesterol, HDL cholesterol and plasma fatty acid composition, diglycerides, cholesterol esters and sphingomyelins,) and related lipid markers
Measured: 8 weeks
Inflammatory genetic variants
Inflammatory genetic variants such as complement component 3, lymphotoxin- α, IL-6, IL-1β, TNF-α, adiponectin polymorphisms and related variants that link to the inflammatory phenotype
Measured: 8 weeks
Functional molecular analysis (ex-vivo)
Functional molecular analysis will be conducted to determine which insulin sensitising pathways have been modulated by the intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- National Children's Research Centre, Ireland, University of Dublin, Trinity College, The Adelaide and Meath Hospital, St. James's Hospital, Ireland
- Responsible party
- Principal investigator, Prof Helen M Roche, University College Dublin
- Investigators
- Helen M Roche, BSc, MSc, PhD, Principal investigator, University College DublinFiona Lithander, BSc, PhD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665742
- Sponsor's protocol ID
- TNS-5
- Status last verified
- Dec 2014
- First submitted
- 12 Aug 2012
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McMorrow AM, Connaughton RM, Magalhaes TR, McGillicuddy FC, Hughes MF, Cheishvili D, Morine MJ, Ennis S, Healy ML, Roche EF, Tremblay RE, Szyf M, Lithander FE, Roche HM. Personalized Cardio-Metabolic Responses to an Anti-Inflammatory Nutrition Intervention in Obese Adolescents: A Randomized Controlled Crossover Trial. Mol Nutr Food Res. 2018 May;62(10):e1701008. doi: 10.1002/mnfr.201701008.
PubMed 29665620
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Anti-inflammatory Dietary Intervention to Improve the Metabolic Phenotype of Overweight and Obese 13-18 Year Old Adolescents - Insights Into Potential Genetic Susceptibility
- ClinicalTrials.gov ID
- NCT01665742
- Acronym / sponsor ID
- TNS-5
- Conditions
- Overweight, Obesity
- Keywords
- Obesity, Chronic inflammation, Anti-inflammatory dietary intervention, Genetic susceptibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- National Children's Research Centre, Ireland, University of Dublin, Trinity College, The Adelaide and Meath Hospital, St. James's Hospital, Ireland
- Study start
- Jan 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of overweight and obese children has increased in Ireland at a greater rate than worldwide trends. The poor eating patterns that drive adolescent obesity leads to an increase in the number of unhealthy inflammatory hormones and fats circulating in the blood which increase an adolescent's risk of developing diabetes and heart disease later in life. Dietary patterns have changed whereby key nutrients that are found in fruit, vegetables and fish, which are known to have beneficial effects and reduce risk of obesity and diabetes in later life, may need to be replaced. This project will determine whether a key anti-inflammatory nutrient supplement taken for 8 weeks will improve the metabolic profile of adolescents aged 13-18 years old. Detailed cellular analysis will determine the cellular and molecular mechanisms to provide a thorough explanation of the health effects of this intervention.
Detailed description
The emerging model of obesity and diabetes is characterised by sub-acute chronic inflammation and insulin resistance. Mechanistic data indicates inflamed adipose tissue with increased infiltration of immune cells that generate pro-inflammatory cytokines. With childhood obesity in Ireland increasing at a rapid pace, it is important to establish the role of a non-pharmacological dietary approach to decreasing the sub-acute chronic inflammation seen in overweight and obese children. Several foods contain nutrients that are known to have anti-inflammatory properties. Such foods including fish, fruits and vegetables are known to be deplete in the adolescent diet. The aim of this project is to investigate whether a nutritional supplement containing anti-inflammatory nutrients, n-3 polyunsaturated fatty acids (found in fish oil), vitamin C, vitamin E, and polyphenols found in green tea and tomato; will improve metabolic phenotype in 13-18 year old teenagers over an 8-week period. Further, to provide insight into the role of genetics in the development of metabolic dysregulation and response to dietary treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory supplement | Active comparator | Dietary Supplement: Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene8-weeks of daily supplementation with: 1 x fruit juice fortified with fish oil, and 4 x film-coated tablets containing vitamin C, alpha-tocopherol, green tea extract and lycopene in conjunction with a weight management programme |
| Placebo supplement | Placebo comparator | Dietary Supplement: Placebo supplement8 weeks of daily supplementation with: 1 x fruit juice fortified with high-oleic sunflower oil, and 4 x film-coated placebo tablets in conjunction with a weight management programme |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male or female
- 13-18 years
- Body mass index ≥ 91st percentile on UK growth reference charts (Cole, 1995)
- Medications/dietary supplements which do not interfere with the intervention are allowed, on condition that the participants adhere to the same regimen during the intervention, including oral contraceptives and other non-fatty acid based dietary supplements (e.g. garlic)
- Smoker or non-smoker
Key exclusion criteria (12 listed)
- Pregnancy or lactation
- Endocrine disorders such as Polycystic Ovary Syndrome
- Currently on treatment for a chronic inflammatory condition such as asthma
- Kidney or liver dysfunction
- Iron deficiency anaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene1 x fruit juice fortified with salmon oil containing 1000mg EPA and 1000mg DHA daily for 8 weeks AND 4 x film-coated tablets containing 561mg vitamin C, 389mg alpha-tocopherol, 416mg green tea extract and 15mg lycopene daily for 8 weeks in conjunction with a weight management programme | Dietary supplement | Anti-inflammatory supplement |
| Placebo supplement1 x fruit juice fortified fortified with high oleic sunflower oil daily for 8 weeks AND 4 x film-coated placebo tablets daily for 8 weeks in conjunction with a weight management programme | Dietary supplement | Placebo supplement |
Primary outcome
Homeostasis model of assessment - insulin resistance
Time frame: 8 weeks
Homeostasis model of assessment - insulin resistance (HOMA-IR) will be derived from fasting glucose and insulin concentrations [(fasting plasma glucose x fasting serum insulin)/22.5] as determined by Matthews et al., 1985
5 secondary outcomes
Adiponectin
Time frame: 8 weeks
Markers of inflammation
Time frame: 8 weeks
Lipid Profile
Time frame: 8 weeks
Inflammatory genetic variants
Time frame: 8 weeks
Functional molecular analysis (ex-vivo)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Derived from this study: PubMed 29665620McMorrow AM, Connaughton RM, Magalhaes TR, McGillicuddy FC, Hughes MF, Cheishvili D, Morine MJ, Ennis S, Healy ML, Roche EF, Tremblay RE, Szyf M, Lithander FE, Roche HM. Personalized Cardio-Metabolic Responses to an Anti-Inflammatory Nutrition Intervention in Obese Adolescents: A Randomized Controlled Crossover Trial. Mol Nutr Food Res. 2018 May;62(10):e1701008. doi: 10.1002/mnfr.201701008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen M Roche, BSc, MSc, PhD principal investigator
University College Dublin
Fiona Lithander, BSc, PhD principal investigator
University of Dublin, Trinity College
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene in people with Overweight and Obesity, run by University College Dublin at 3 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis model of assessment - insulin resistance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01665742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.