The Effect of CLA on Obesity, Lung Functions, Lipid Profile and Inflammation in Women With BMI≥25

NCT04641494 | Completed

• 1 other identifier: 1141/16/HH/CSN
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obesity; Lung Functions; Inflammation; Lipid Disorder

Keywords

Conjugated linoleic caid; Obesity; Lung functions; Inflammation; heat shock proteins; Adhesion molecules

Outcome Measures

Primary Outcomes (8)

• The change in body weight from baseline to 12 weeks

  Body weight (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)

  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

  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)

  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)

  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)

  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)

  0, 6, 12 Weeks

• The change in waist circumference from baseline to 12 weeks

  Waist circumference will be measured by cm using the tab

  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

  0, 6, 12 Weeks

Secondary Outcomes (4)

• The change in Total Cholesterol (TC) from baseline to 12 weeks

  0, 6, 12 weeks

• The change in Triglycerides (TG) from baseline to 12 weeks

  0, 6, 12 weeks

• The change in Low Density Lipoprotein (LDL) from baseline to 12 weeks

  0, 6, 12 weeks

• The change in (High Density Lipoprotein) HDL from baseline to 12 weeks

  0, 6, 12 weeks

Other Outcomes (11)

• The change in (Forced Expiratory Volume) FEV% predicted from baseline to 12 weeks

  0, 6, 12 weeks

• The change in (Forced Vital Capacity) FVC% predicted from baseline to 12 weeks

  0, 6, 12 weeks

• The change in (Peak of Flow) PEF% predicted from baseline to 12 weeks

  0, 6, 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

28 subject received 2 capsules 3times a day for 12 weeks Each capsule contain 1gm (High Oleic Acid Safflower oils)

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

Dietary Supplement: Conjugated linoleic acid

Interventions

Conjugated linoleic acid DIETARY_SUPPLEMENT

CLA Mixture capsule (50:50, c9, t11-CLA: t10, c12-CLA)

Also known as: CLA

CLA group

High oleic acid safflower oil capsules DIETARY_SUPPLEMENT

Also known as: HOSFO

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to swallow capsules
• Overweight and obese women (BMI≥25)
• Forced expiratory volume FEV1≥ 70%

You may not qualify if:

• Participants taking antibiotics,
• Participants taking weight loss medications
• Pregnant and breastfeeding women,
• Women with current or a history of severe lung disease

Sponsors & Collaborators

• University of Chester: lead

Study Sites (1)

University of Chester

Chester, Cheshire, CH2 1BR, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Inflammation; Lipid Metabolism Disorders

Interventions

Linoleic Acids, Conjugated

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Linoleic Acids; Fatty Acids, Omega-6; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Hanady Hamdallah, PhD

  University of Chester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: November 23, 2020
• Study Start: November 11, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2018
• Last Updated: November 23, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)