ObesityNCT04641494
The Effect of CLA on Obesity, Lung Functions, Lipid Profile and Inflammation in Women With BMI≥25
A study testing Conjugated linoleic acid and High oleic acid safflower oil capsules in people with Obesity and Lung Functions, run by University of Chester at 1 site in United Kingdom.
Trial summary
Conjugated linoleic acid or CLA, is one of the food supplements that could be found in meat, fats, and dairy products of ruminants which has been fed grass not on grains. CLA has shown anti-cancer, anti-obesity, and anti-inflammatory effects in several animal modules, but the results of the human studies were not… Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Lung Functions, Inflammation
- What is being tested?
- Conjugated linoleic acid and High oleic acid safflower oil capsules
- 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
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2016to 1 Aug 2018
- 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 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to swallow capsules
- Overweight and obese women (BMI≥25)
- Forced expiratory volume FEV1≥ 70%
Who cannot join
- Participants taking antibiotics,
- Participants taking weight loss medications
- Pregnant and breastfeeding women,
- Women with current or a history of severe lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 12 Weeks of Conjugated Linoleic Acid on Obesity Markers, Lung Functions, Lipid Profile and Inflammation in Overweight and Obese Women: Double-blind Randomised Control Trial.
Conjugated linoleic acid or CLA, is one of the food supplements that could be found in meat, fats, and dairy products of ruminants which has been fed grass not on grains. CLA has shown anti-cancer, anti-obesity, and anti-inflammatory effects in several animal modules, but the results of the human studies were not consistent. Also, a very limited number of studies looked at the CLA effect on the respiratory system. The study will look at the effect of 12 weeks of supplementation of conjugated linoleic acid on obesity markers, lung functions, lipid profile, and inflammation in overweight and obese women in a double-blind randomized control trial.
The study looked at the inflammation using different approaches, where it looked at the expression of adhesion molecules on the proinflammatory monocytes as well as it analysed the expression of the stress proteins Heat-shock proteins (HSPA1A and HSPB1)on the PBMCs.
Read the detailed description
This is a double-blind randomized control trial with parallel design, where consented overweight and obese women from Chester city in the UK will be randomly assigned into two groups one group CLA will receive 4.5 g/day CLA mixture capsules while the other group will receive a placebo.
Participants will attend three clinics and by the end of each clinic, the participants will be asked to provide 20 ml venous blood samples for the analysis of the biological marker. Participants' anthropometric, body composition, lung functions, Leptin adiponectin, lipid profile, Adhesion molecules CD14, CD16, CD11b, and CD62L, HSPA1A, and HSPB1 will be assessed at three time points, at baseline after 6 and 12 weeks. The level of CLA in the plasma, as well as lipid profile (HDL, LDL, TC, TG), will be measured at each time point
Participants will be asked to fill three food diaries before attending each clinic. Body composition will be measured using bioelectric impedance, lung functions will be assessed using spirometers, adiponectin and leptin will be assessed using ELISA, and finally, CD11b, CD62L, HSPA1A, and HSPB1 will be analysed using flow cytometer. Plasma level of c9, t11-CLA and t10, c12-CLA will be measured using flame ionized Gas chromatography, and the lipid profile will be assessed using ALERE AFINION™ AS100 ANALYZER.
Power calculation for the RCT Sample size calculation is done using G*Power software, a total of 20 participant is required, 10 participants in each group, to get an effect size of 1.3 kg/m2 change in BMI from baseline and SD of 0.45, 0.05 margin of error, 95% power and 95% confidence interval. Considering a 150% drop out the total number will be 50, 25 in each group.
Participants' randomisation will be performed by an independent third party who is not involved in the current trial. Participants will be randomised into blocks using (www.randomization.com) which generate the randomisation plan. All the capsules will be packed in a light protective dark brown tamper-proof container. The randomised participants will be either allocated to the CLA group or the placebo group. CLA and placebo capsules will have the same shape and colour, and both the participants and researcher will be blind to the treatments.
Statistical analysis. IBM SPSS Statistic Data Editor Software (version25) will be used for the statistical analysis of this trial while the graphs will be made using GraphPad Prism version 7.
Descriptive statistics of baseline continuous data will be expressed in form of mean± standard error of the mean (SEM). Nominal data will be expressed in percentages. The parametric assumption will be checked using Shapiro-Wilk tests at a significant level p< 0.05. The differences between the baseline characteristics in CLA and the placebo group will be done using an independent t-test in parametric data or Mann Whitney U for non-parametric data, at a significant level P<0.05.
Testing the effects of CLA compared to placebo and the interaction with times (baseline, 6 weeks, and 12 weeks) will be done using Mixed Model Repeated Measures Analysis of Variance (ANOVA) at a significant level p< 0.05. The later analysis will be useing Tukey post hoc test with Bonferroni correction for all the measured parameters.
A paired t-test or Wilcoxon test will be done to detect the difference within- participants at different time points in parametric and non-parametric data, respectively, at a significant level P<0.05. Independent t-test or Mann Whitney U will be used to detect the difference between the CLA group and placebo across the different time points for normally and non-normally distributed data, respectively at a significant level P<0.05.
The difference in the change at week 6 compared to baseline, (∆ 6 weeks), and at week 12 compared to baseline (∆ 12 weeks), in CLA groups compared to placebo will be checked using t-test in case of normally distributed data or Mann Whitney-U for non-parametric data at significant level P<0.05. The difference between the categorical data will be done using the Chi-square test at a significant level p<0.05.
Obesity hypotheses
H1: There is a significant reduction in BMI in CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in BMI in CLA supplemented group compared to the placebo group.
H2: There is a significant reduction in BW in the CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in BW in the CLA supplemented group compared to the placebo group.
H3: There is a significant reduction in WHR in CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in WHR in CLA supplemented group compared to the placebo group.
H5: There is a significant increase in LBM in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in LBM in CLA supplemented group compared to the placebo group.
H6: There is a significant increase in %LBM in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %LBM in CLA supplemented group compared to the placebo group.
H8: There is a significant reduction in TBF in CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in TBF in CLA supplemented group compared to the placebo group.
H9: There is a significant reduction in %BF in CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in %BF in CLA supplemented group compared to the placebo group.
H10: There is a significant increase in the basal metabolic rate in the CLA supplemented group compared to the placebo group.
H0: There is no significant increase in the basal metabolic rate in the CLA supplemented group compared to the placebo group.
Lung function hypotheses Primary hypothesis H1: There is a significant increase in %PEF predicted in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %PEF predicted in CLA supplemented group compared to the placebo group.
Secondary hypotheses. H2: There is a significant increase in %FEV1 predicted in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %FEV1 predicted in CLA supplemented group compared to the placebo group.
H3: There is a significant increase in %FVC predicted in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %FVC predicted in CLA supplemented group compared to the placebo group.
H8: There is a significant increase in %FEV1/FVC predicted in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %FEV1/ FVC predicted in CLA supplemented group compared to the placebo group.
8.6.3 Adipokines hypotheses Primary hypothesis H1: There is a significant reduction in leptin in the CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in leptin in the CLA supplemented group compared to the placebo group.
Secondary hypothesis. H2: There is a significant increase in adiponectin in the CLA supplemented group compared to the placebo group.
H0: There is no significant increase in adiponectin in the CLA supplemented group compared to the placebo group.
8.6.4 Inflammation hypotheses Primary hypothesis H1: there is a significant change in the expression of HSPA1A on PBMCs in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPA1A on PBMCs in the CLA group compared to the placebo group.
Secondary hypotheses H2: there is a significant change in the expression of HSPA1A on lymphocytes in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPA1A on lymphocytes in the CLA group compared to the placebo group.
H3: there is a significant change in the expression of HSPA1A on monocytes in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPA1A on monocytes in the CLA group compared to the placebo group.
H4: there is a significant change in the expression of HSPB1on PBMCs in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPB1 on PBMCs in the CLA group compared to the placebo group.
H5: there is a significant change in the expression of HSPB1 on lymphocytes in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPB1 on lymphocytes in the CLA group compared to the placebo group.
H6: there is a significant change in the expression of HSPB1 on monocytes in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPB1 on monocytes in the CLA group compared to the placebo group.
H7: there is a significant change in the expression of CD11b on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of CD11b on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H8: there is a significant change in the expression of CD11b on pro-inflammatory monocytes (CD14++CD16+) after 100ng/ml LPS stimulation for one hour in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of CD11b on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H9: there is a significant change in the increase of CD11b expression on pro-inflammatory monocytes (CD14++CD16+) after LPS stimulation in the CLA group compared to the placebo group.
H0: there is no significant difference H8: there is a significant change in the increase of CD11b expression on pro-inflammatory monocytes (CD14++CD16+) after LPS stimulation in the CLA group compared to the placebo group.
H10: there is a significant change in the expression of CD62L on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of CD62L CD11b on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H11: there is a significant change in the expression of CD62L on pro-inflammatory monocytes (CD14++CD16+) after 100ng/ml LPS stimulation for one hour in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of CD62L on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H12: there is a significant change in the reduction of CD62L expression on pro-inflammatory monocytes (CD14++CD16+) after LPS stimulation in the CLA group compared to the placebo group.
H0: there is no significant change in the reduction of CD62L expression on pro-inflammatory monocytes (CD14++CD16+) after LPS stimulation in the CLA group compared to the placebo group.
Lipid profile hypotheses H1: there is a significant change in the level of LDL in the CLA group compared to the placebo group.
H0: there is no significant change in the level of LDL in the CLA group compared to the placebo group.
H2: there is a significant change in the level of HDL in the CLA group compared to the placebo group.
H0: there is no significant change in the level of HDL in the CLA group compared to the placebo group.
H3: there is a significant change in the level of TC in the CLA group compared to the placebo group.
H0: there is no significant change in the level of TC in the CLA group compared to the placebo group.
H4: there is a significant change in the level of TG in the CLA group compared to the placebo group.
H0: there is no significant change in the level of TG in the CLA group compared to the placebo group.
- Conditions
- Obesity, Lung Functions, Inflammation, Lipid Disorder
- Being tested
- Conjugated linoleic acid, High oleic acid safflower oil capsules
- Keywords
- Conjugated linoleic caid, Obesity, Lung functions, Inflammation, heat shock proteins, Adhesion molecules
- Medical subject headings
- Obesity, Inflammation, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjugated linoleic acidDietary supplement
Also called CLA
CLA Mixture capsule (50:50, c9, t11-CLA: t10, c12-CLA)
High oleic acid safflower oil capsulesDietary supplement
Also called HOSFO
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 28 subject received 2 capsules 3times a day for 12 weeks Each capsule contain 1gm (High Oleic Acid Safflower oils) Receives: Dietary Supplement: High oleic acid safflower oil capsules |
| CLA group | Active comparator | Participants received 2 capsules3 times a day for 12 weeks Each capsule is 1 gm and it provided 0.75 gm CLA in a 50:50 mixture Receives: Dietary Supplement: Conjugated linoleic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in body weight from baseline to 12 weeks
Body weight (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
Measured: 0, 6, 12 Weeks
The change in BMI from baseline to 12 weeks
weight and height will be combined to report BMI in kg/m^2
Measured: 0, 6, 12 Weeks
The change in total body fat from baseline to 12 weeks
total body fat (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
Measured: 0, 6, 12 Weeks
The change in percentage body fat from baseline to 12 weeks
Percentage body fat will be measured using Bioelectric impedance technique (Tanita MC-780)
Measured: 0, 6, 12 Weeks
The change in Lean body mass from baseline to 12 weeks
Lean body mass (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
Measured: 0, 6, 12 Weeks
The change in percentage lean body mass from baseline to 12 weeks
Percentage lean body mass will be measured using Bioelectric impedance technique (Tanita MC-780)
Measured: 0, 6, 12 Weeks
The change in waist circumference from baseline to 12 weeks
Waist circumference will be measured by cm using the tab
Measured: 0, 6, 12 Weeks
The change in waist to hip ratio from baseline to 12 weeks
Waist to hip ratio will be calculated by dividing the waist circumference cm over the hip circumference
Measured: 0, 6, 12 Weeks
Secondary outcomes (4)
The change in Total Cholesterol (TC) from baseline to 12 weeks
TC mmol/l was measured by (Alere Afinion™ AS100 Analyzer)with test cartridges (Alere Afinion™ Lipid Panel).
Measured: 0, 6, 12 weeks
The change in Triglycerides (TG) from baseline to 12 weeks
TG (mmol/l)was measured by (Alere Afinion™ AS100 Analyzer)with test cartridges (Alere Afinion™ Lipid Panel).
Measured: 0, 6, 12 weeks
The change in Low Density Lipoprotein (LDL) from baseline to 12 weeks
LDL (mmol/l) was measured by (Alere Afinion™ AS100 Analyzer)with test cartridges (Alere Afinion™ Lipid Panel).
Measured: 0, 6, 12 weeks
The change in (High Density Lipoprotein) HDL from baseline to 12 weeks
HDL (mmol/l) was measured by (Alere Afinion™ AS100 Analyzer) with test cartridges (Alere Afinion™ Lipid Panel).
Measured: 0, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start11 Nov 2016
- Primary completion1 Aug 2017
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanady Hamdallah, PhD, Principal investigator, University of Chester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641494
- Sponsor's protocol ID
- 1141/16/HH/CSN
- Status last verified
- Aug 2020
- First submitted
- 16 Sep 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The results will be available in the thesis form and possibly publication. It will be available in the thesis form in 2022 and publication expected to be in 2021.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 12 Weeks of Conjugated Linoleic Acid on Obesity Markers, Lung Functions, Lipid Profile and Inflammation in Overweight and Obese Women: Double-blind Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT04641494
- Acronym / sponsor ID
- 1141/16/HH/CSN
- Conditions
- Obesity, Lung Functions, Inflammation, Lipid Disorder
- Keywords
- Conjugated linoleic caid, Obesity, Lung functions, Inflammation, heat shock proteins, Adhesion molecules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ChesterUniversity, hospital or other
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 23 Nov 2020 (actual)
- 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.
Conjugated linoleic acid or CLA, is one of the food supplements that could be found in meat, fats, and dairy products of ruminants which has been fed grass not on grains. CLA has shown anti-cancer, anti-obesity, and anti-inflammatory effects in several animal modules, but the results of the human studies were not consistent. Also, a very limited number of studies looked at the CLA effect on the respiratory system. The study will look at the effect of 12 weeks of supplementation of conjugated linoleic acid on obesity markers, lung functions, lipid profile, and inflammation in overweight and obese women in a double-blind randomized control trial.
The study looked at the inflammation using different approaches, where it looked at the expression of adhesion molecules on the proinflammatory monocytes as well as it analysed the expression of the stress proteins Heat-shock proteins (HSPA1A and HSPB1)on the PBMCs.
Detailed description
This is a double-blind randomized control trial with parallel design, where consented overweight and obese women from Chester city in the UK will be randomly assigned into two groups one group CLA will receive 4.5 g/day CLA mixture capsules while the other group will receive a placebo.
Participants will attend three clinics and by the end of each clinic, the participants will be asked to provide 20 ml venous blood samples for the analysis of the biological marker. Participants' anthropometric, body composition, lung functions, Leptin adiponectin, lipid profile, Adhesion molecules CD14, CD16, CD11b, and CD62L, HSPA1A, and HSPB1 will be assessed at three time points, at baseline after 6 and 12 weeks. The level of CLA in the plasma, as well as lipid profile (HDL, LDL, TC, TG), will be measured at each time point
Participants will be asked to fill three food diaries before attending each clinic. Body composition will be measured using bioelectric impedance, lung functions will be assessed using spirometers, adiponectin and leptin will be assessed using ELISA, and finally, CD11b, CD62L, HSPA1A, and HSPB1 will be analysed using flow cytometer. Plasma level of c9, t11-CLA and t10, c12-CLA will be measured using flame ionized Gas chromatography, and the lipid profile will be assessed using ALERE AFINION™ AS100 ANALYZER.
Power calculation for the RCT Sample size calculation is done using G*Power software, a total of 20 participant is required, 10 participants in each group, to get an effect size of 1.3 kg/m2 change in BMI from baseline and SD of 0.45, 0.05 margin of error, 95% power and 95% confidence interval. Considering a 150% drop out the total number will be 50, 25 in each group.
Participants' randomisation will be performed by an independent third party who is not involved in the current trial. Participants will be randomised into blocks using (www.randomization.com) which generate the randomisation plan. All the capsules will be packed in a light protective dark brown tamper-proof container. The randomised participants will be either allocated to the CLA group or the placebo group. CLA and placebo capsules will have the same shape and colour, and both the participants and researcher will be blind to the treatments.
Statistical analysis. IBM SPSS Statistic Data Editor Software (version25) will be used for the statistical analysis of this trial while the graphs will be made using GraphPad Prism version 7.
Descriptive statistics of baseline continuous data will be expressed in form of mean± standard error of the mean (SEM). Nominal data will be expressed in percentages. The parametric assumption will be checked using Shapiro-Wilk tests at a significant level p< 0.05. The differences between the baseline characteristics in CLA and the placebo group will be done using an independent t-test in parametric data or Mann Whitney U for non-parametric data, at a significant level P<0.05.
Testing the effects of CLA compared to placebo and the interaction with times (baseline, 6 weeks, and 12 weeks) will be done using Mixed Model Repeated Measures Analysis of Variance (ANOVA) at a significant level p< 0.05. The later analysis will be useing Tukey post hoc test with Bonferroni correction for all the measured parameters.
A paired t-test or Wilcoxon test will be done to detect the difference within- participants at different time points in parametric and non-parametric data, respectively, at a significant level P<0.05. Independent t-test or Mann Whitney U will be used to detect the difference between the CLA group and placebo across the different time points for normally and non-normally distributed data, respectively at a significant level P<0.05.
The difference in the change at week 6 compared to baseline, (∆ 6 weeks), and at week 12 compared to baseline (∆ 12 weeks), in CLA groups compared to placebo will be checked using t-test in case of normally distributed data or Mann Whitney-U for non-parametric data at significant level P<0.05. The difference between the categorical data will be done using the Chi-square test at a significant level p<0.05.
Obesity hypotheses
H1: There is a significant reduction in BMI in CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in BMI in CLA supplemented group compared to the placebo group.
H2: There is a significant reduction in BW in the CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in BW in the CLA supplemented group compared to the placebo group.
H3: There is a significant reduction in WHR in CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in WHR in CLA supplemented group compared to the placebo group.
H5: There is a significant increase in LBM in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in LBM in CLA supplemented group compared to the placebo group.
H6: There is a significant increase in %LBM in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %LBM in CLA supplemented group compared to the placebo group.
H8: There is a significant reduction in TBF in CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in TBF in CLA supplemented group compared to the placebo group.
H9: There is a significant reduction in %BF in CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in %BF in CLA supplemented group compared to the placebo group.
H10: There is a significant increase in the basal metabolic rate in the CLA supplemented group compared to the placebo group.
H0: There is no significant increase in the basal metabolic rate in the CLA supplemented group compared to the placebo group.
Lung function hypotheses Primary hypothesis H1: There is a significant increase in %PEF predicted in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %PEF predicted in CLA supplemented group compared to the placebo group.
Secondary hypotheses. H2: There is a significant increase in %FEV1 predicted in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %FEV1 predicted in CLA supplemented group compared to the placebo group.
H3: There is a significant increase in %FVC predicted in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %FVC predicted in CLA supplemented group compared to the placebo group.
H8: There is a significant increase in %FEV1/FVC predicted in CLA supplemented group compared to the placebo group.
H0: There is no significant increase in %FEV1/ FVC predicted in CLA supplemented group compared to the placebo group.
8.6.3 Adipokines hypotheses Primary hypothesis H1: There is a significant reduction in leptin in the CLA supplemented group compared to the placebo group.
H0: There is no significant reduction in leptin in the CLA supplemented group compared to the placebo group.
Secondary hypothesis. H2: There is a significant increase in adiponectin in the CLA supplemented group compared to the placebo group.
H0: There is no significant increase in adiponectin in the CLA supplemented group compared to the placebo group.
8.6.4 Inflammation hypotheses Primary hypothesis H1: there is a significant change in the expression of HSPA1A on PBMCs in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPA1A on PBMCs in the CLA group compared to the placebo group.
Secondary hypotheses H2: there is a significant change in the expression of HSPA1A on lymphocytes in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPA1A on lymphocytes in the CLA group compared to the placebo group.
H3: there is a significant change in the expression of HSPA1A on monocytes in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPA1A on monocytes in the CLA group compared to the placebo group.
H4: there is a significant change in the expression of HSPB1on PBMCs in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPB1 on PBMCs in the CLA group compared to the placebo group.
H5: there is a significant change in the expression of HSPB1 on lymphocytes in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPB1 on lymphocytes in the CLA group compared to the placebo group.
H6: there is a significant change in the expression of HSPB1 on monocytes in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of HSPB1 on monocytes in the CLA group compared to the placebo group.
H7: there is a significant change in the expression of CD11b on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of CD11b on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H8: there is a significant change in the expression of CD11b on pro-inflammatory monocytes (CD14++CD16+) after 100ng/ml LPS stimulation for one hour in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of CD11b on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H9: there is a significant change in the increase of CD11b expression on pro-inflammatory monocytes (CD14++CD16+) after LPS stimulation in the CLA group compared to the placebo group.
H0: there is no significant difference H8: there is a significant change in the increase of CD11b expression on pro-inflammatory monocytes (CD14++CD16+) after LPS stimulation in the CLA group compared to the placebo group.
H10: there is a significant change in the expression of CD62L on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of CD62L CD11b on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H11: there is a significant change in the expression of CD62L on pro-inflammatory monocytes (CD14++CD16+) after 100ng/ml LPS stimulation for one hour in the CLA group compared to the placebo group.
H0: there is no significant change in the expression of CD62L on pro-inflammatory monocytes (CD14++CD16+) in the CLA group compared to the placebo group.
H12: there is a significant change in the reduction of CD62L expression on pro-inflammatory monocytes (CD14++CD16+) after LPS stimulation in the CLA group compared to the placebo group.
H0: there is no significant change in the reduction of CD62L expression on pro-inflammatory monocytes (CD14++CD16+) after LPS stimulation in the CLA group compared to the placebo group.
Lipid profile hypotheses H1: there is a significant change in the level of LDL in the CLA group compared to the placebo group.
H0: there is no significant change in the level of LDL in the CLA group compared to the placebo group.
H2: there is a significant change in the level of HDL in the CLA group compared to the placebo group.
H0: there is no significant change in the level of HDL in the CLA group compared to the placebo group.
H3: there is a significant change in the level of TC in the CLA group compared to the placebo group.
H0: there is no significant change in the level of TC in the CLA group compared to the placebo group.
H4: there is a significant change in the level of TG in the CLA group compared to the placebo group.
H0: there is no significant change in the level of TG in the CLA group compared to the placebo group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: High oleic acid safflower oil capsules28 subject received 2 capsules 3times a day for 12 weeks Each capsule contain 1gm (High Oleic Acid Safflower oils) |
| CLA group | Active comparator | Dietary Supplement: Conjugated linoleic acidParticipants received 2 capsules3 times a day for 12 weeks Each capsule is 1 gm and it provided 0.75 gm CLA in a 50:50 mixture |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to swallow capsules
- Overweight and obese women (BMI≥25)
- Forced expiratory volume FEV1≥ 70%
Key exclusion criteria (4 listed)
- Participants taking antibiotics,
- Participants taking weight loss medications
- Pregnant and breastfeeding women,
- Women with current or a history of severe lung disease
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 |
|---|---|---|
| Conjugated linoleic acidAlso: CLACLA Mixture capsule (50:50, c9, t11-CLA: t10, c12-CLA) | Dietary supplement | CLA group |
| High oleic acid safflower oil capsulesAlso: HOSFO | Dietary supplement | Placebo |
Primary outcome
The change in body weight from baseline to 12 weeks
Time frame: 0, 6, 12 Weeks
Body weight (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in BMI from baseline to 12 weeks
Time frame: 0, 6, 12 Weeks
weight and height will be combined to report BMI in kg/m^2
The change in total body fat from baseline to 12 weeks
Time frame: 0, 6, 12 Weeks
total body fat (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in percentage body fat from baseline to 12 weeks
Time frame: 0, 6, 12 Weeks
Percentage body fat will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in Lean body mass from baseline to 12 weeks
Time frame: 0, 6, 12 Weeks
Lean body mass (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in percentage lean body mass from baseline to 12 weeks
Time frame: 0, 6, 12 Weeks
Percentage lean body mass will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in waist circumference from baseline to 12 weeks
Time frame: 0, 6, 12 Weeks
Waist circumference will be measured by cm using the tab
The change in waist to hip ratio from baseline to 12 weeks
Time frame: 0, 6, 12 Weeks
Waist to hip ratio will be calculated by dividing the waist circumference cm over the hip circumference
4 secondary outcomes
The change in Total Cholesterol (TC) from baseline to 12 weeks
Time frame: 0, 6, 12 weeks
The change in Triglycerides (TG) from baseline to 12 weeks
Time frame: 0, 6, 12 weeks
The change in Low Density Lipoprotein (LDL) from baseline to 12 weeks
Time frame: 0, 6, 12 weeks
The change in (High Density Lipoprotein) HDL from baseline to 12 weeks
Time frame: 0, 6, 12 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 23 Nov 2020.
- Individual participant dataSharing planned: No. The results will be available in the thesis form and possibly publication. It will be available in the thesis form in 2022 and publication expected to be in 2021.
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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.
Hanady Hamdallah, PhD principal investigator
University of Chester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conjugated linoleic acid and High oleic acid safflower oil capsules in people with Obesity and Lung Functions, run by University of Chester at 1 site in United Kingdom.
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 3 inclusion and 4 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 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The change in body weight from baseline to 12 weeks (time frame: 0, 6, 12 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2020.