Oxidative StressNCT05404217
Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.
A study testing LN-OS-22 and Maltodextrin in people with Oxidative Stress, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
Trial summary
The present clinical investigation has been proposed to further substantiate the evidence of the antioxidant and anti-inflammatory activity of the extract in the healthy adult population with BMI ranging from ≥25.0 kg/m2 and ≤ 34.9 kg/m2 . Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- LN-OS-22 and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 3 sitesIndia
- Study dates
- 16 Jun 2022to 13 Mar 2023
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged ≥30 -≤60 years.
- No history of systemic infection as assessed by normal total leucocyte count.
- Overweight and obese participants (at high risk of oxidative stress and inflammation) identified as BMI ≥ 25.0 kg/m2 and ≤ 34.9 kg/m2
- Individuals having a risk of metabolic syndrome as indicated by three or more of the following five criteria:
- a Waist circumference more than 102 cm for males or 88 cm for females b Blood pressure of more than 130/85 mmHg c Fasting triglyceride (TG) level ≥ 150 mg/dl d Fasting high-density lipoprotein cholesterol level ≤ 40 mg/dl for males or 50 mg/dl for females e Fasting blood glucose ≥ 100 mg/dl.
- Individuals physically inactive for 1/3rd of the wake time as per the Longitudinal Aging Study Amsterdam (LASA) sedentary behavior questionnaire
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- Non-smokers (Past smokers can be allowed if they have abstinence for a minimum of 2 years)
- Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study interventions, blood and urine sample collection procedures, and study visit schedule)
- Participants who are literate enough to read and understand the consent form and provide voluntary consent.
- Participants who can give written informed consent and willing to participate in the study and comply with its procedures.
Who cannot join
- Known sensitivity to the investigational product or any excipients of the drug product.
- Known case of lactose intolerance.
- Known case of type I diabetes.
- Presence of uncontrolled type II diabetes mellitus (indicated by HbA1c ≥ 6.5).
- Presence of uncontrolled hypertension (defined as Systolic Blood Pressure (SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg).
- Presence thyroid dysfunction (defined as thyroid stimulating hormone (TSH) level < 0.4 to > 4.2 mIU/L).
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- Participants with moderate to severe anemia defined as hemoglobin <10 gm/dL- in the case of females and < 11 gm/dL- in the case of males will be excluded from the study.
- Consumption of any herbal preparation, supplements, nutritional therapy, etc. which is expected to reduce oxidative stress within 1 month prior to screening and throughout the study period.
- History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's endpoints.
- History of use of anti-inflammatory therapies for any ailments within 7 days prior to randomization.
- Participation in other clinical trials in the last 3 months prior to screening
- Participants with substance abuse problems (within 2 years) defined as:
- a Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- b High-risk drinking as defined by the consumption of 4 or more alcohol-containing beverages on any day or 8 or more alcohol-containing beverages per week for women and 5 or more alcohol-containing beverages on any day or 15 or more alcohol-containing beverages per week for men.
- Participants who have a clinically significant disorder such as cardiovascular, endocrine, respiratory, gastrointestinal, hepatobiliary, kidney, urinary, hematological, immunity, neuropsychiatric, musculoskeletal, inflammatory, and/or tumors.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes
Trial locations and contacts
3 sites in 1 country.
India3 sites
Ayush Nursing Home
Mumbai, Maharashtra, 400067
Dr. Awate's Clinic
Mumbai, Maharashtra, 400067
Metabol-Lifestyle metabolic syndrome clinic
Mumbai, Maharashtra, 400086
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.
The present clinical investigation has been proposed to further substantiate the evidence of the antioxidant and anti-inflammatory activity of the extract in the healthy adult population with BMI ranging from ≥25.0 kg/m2 and ≤ 34.9 kg/m2 . The antioxidant effect of the 56 days of oral administration of the extract (1000 mg/day) will be primarily assessed by change in the level of 8-isoprostane from baseline to the end of the study and the anti-inflammatory activity of the extract will be investigated by the change in the level of CRP and IL-6. In addition, the effect on lipid peroxidation and DNA damage will be assessed by serum level of MDA before and after 2 months of extract administration. Further, metabolic endotoxemia will be assessed by the change in the plasma level of lipopolysaccharides. Weight and waist circumference are included as secondary outcomes as the clinical indicators of reduction in oxidative stress and inflammation. Overweight and obesity significantly impact the health-related quality of life31 in the affected individuals and flavonoids have previously been shown to improve the quality of life in controlled clinical studies therefore, Investigator included health-related quality of life as a secondary objective of the study. The safety of the 2-month administration of the extract will be examined by a change in the vitals, liver, and kidney function biomarkers (SGOT, SGPT, ALP, and creatinine).
- Conditions
- Oxidative Stress
- Being tested
- LN-OS-22, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LN-OS-22Other
2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days
MaltodextrinOther
2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days
| Study group | Role | What they receive |
|---|---|---|
| LN-OS-22 | Active comparator | 2 capsules orally once a day for 56 days Receives: Other: LN-OS-22 |
| Maltodextrin | Placebo comparator | 2 capsules orally once a day for 56 days Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress
To measure the oxidative stress 8-iso-PGF2α which is considered the best biomarker of oxidative stress will be assessed in the serum of the participants enrolled in the study. The blood sample will then be sent to the laboratory for analysis of serum levels of 8-iso-PGF2α by sandwich ELISA technique using GENLISATM ELISA kits. The normal reference range of 8-iso-PGF2α is 2-34 pg/ml (median).
oxidative stress as assessed by change in serum levels of 8-isoprostane
Measured: days 0, day 28, and day 56.
Secondary outcomes (5)
Systemic inflammation CRP and IL - 6
blood sample will then be sent to the laboratory for estimation of CRP by RHELAX-CRP slide test based on the principle of agglutination. Serum IL-6 will be estimated by using GENLISATM ELISA kits. The normal reference range of CRP is <10 mg/L and that of IL-6 is 0-50 pg/mL.
Measured: days 0, day 28, and day 56.
Metabolic endotoxemia
The samples will be sent to the laboratory for the assessment of LPS by sandwich ELISA technique using GENLISATM ELISA kits. Reference range: Median (IQR) = 18.4 (8.6-56.8) μg/ml. Metabolic endotoxemia as assessed by change in plasma lipopolysaccharide levels post high-fat diet from baseline compared to placebo.
Measured: days 0, and day 56.
Body weight
Participants will be weighed on a calibrated digital weighing scale (with minimal clothing and bare feet) on the screening visit, day 0, and monthly follow-up visits before taking breakfast. The body weight measurement will be taken twice, and if the difference between the two readings is greater than 1 kg, then a third measurement will be taken.
Higher the body weight represents the worst scoring , lower the body weight represents best scoring
Measured: days 0, day 28, and day 56.
Waist circumference
The waist circumference will be measured (in cm) at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, using stretch-resistant tape. The measurement will be taken twice, and if the difference between the two readings is greater than 1 cm, then a third measurement will be taken.
Higher the waist circumference represents the worst scoring , lower the body weight represents best scoring
Measured: days 0, day 28, and day 56.
Impact of Weight on Quality of Life-Lite-Clinical Trials
Quality of life as assessed by change in the scores of Impact of Weight on Quality of Life-Lite-Clinical Trials Version from baseline. The higher the score, the greater will be impairment in quality of life.85
Measured: days 0, day 28, and day 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start16 Jun 2022
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled parallel-group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Shalini Srivastava, MD medicine, Study director, Vedic Lifesciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404217
- Sponsor's protocol ID
- LI/211202/SOPH/OSSI
- Status last verified
- Apr 2023
- First submitted
- 30 May 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.
- ClinicalTrials.gov ID
- NCT05404217
- Acronym / sponsor ID
- LI/211202/SOPH/OSSI
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 3 Jun 2022 (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.
The present clinical investigation has been proposed to further substantiate the evidence of the antioxidant and anti-inflammatory activity of the extract in the healthy adult population with BMI ranging from ≥25.0 kg/m2 and ≤ 34.9 kg/m2 . The antioxidant effect of the 56 days of oral administration of the extract (1000 mg/day) will be primarily assessed by change in the level of 8-isoprostane from baseline to the end of the study and the anti-inflammatory activity of the extract will be investigated by the change in the level of CRP and IL-6. In addition, the effect on lipid peroxidation and DNA damage will be assessed by serum level of MDA before and after 2 months of extract administration. Further, metabolic endotoxemia will be assessed by the change in the plasma level of lipopolysaccharides. Weight and waist circumference are included as secondary outcomes as the clinical indicators of reduction in oxidative stress and inflammation. Overweight and obesity significantly impact the health-related quality of life31 in the affected individuals and flavonoids have previously been shown to improve the quality of life in controlled clinical studies therefore, Investigator included health-related quality of life as a secondary objective of the study. The safety of the 2-month administration of the extract will be examined by a change in the vitals, liver, and kidney function biomarkers (SGOT, SGPT, ALP, and creatinine).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled parallel-group
| Arm | Type | Receives |
|---|---|---|
| LN-OS-22 | Active comparator | Other: LN-OS-222 capsules orally once a day for 56 days |
| Maltodextrin | Placebo comparator | Other: Maltodextrin2 capsules orally once a day for 56 days |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males and females aged ≥30 -≤60 years.
- No history of systemic infection as assessed by normal total leucocyte count.
- Overweight and obese participants (at high risk of oxidative stress and inflammation) identified as BMI ≥ 25.0 kg/m2 and ≤ 34.9 kg/m2
- Individuals having a risk of metabolic syndrome as indicated by three or more of the following five criteria:
- a Waist circumference more than 102 cm for males or 88 cm for females b Blood pressure of more than 130/85 mmHg c Fasting triglyceride (TG) level ≥ 150 mg/dl d Fasting high-density lipoprotein cholesterol level ≤ 40 mg/dl for males or 50 mg/dl for females e Fasting blood glucose ≥ 100 mg/dl.
Key exclusion criteria (17 listed)
- Known sensitivity to the investigational product or any excipients of the drug product.
- Known case of lactose intolerance.
- Known case of type I diabetes.
- Presence of uncontrolled type II diabetes mellitus (indicated by HbA1c ≥ 6.5).
- Presence of uncontrolled hypertension (defined as Systolic Blood Pressure (SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg).
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 |
|---|---|---|
| LN-OS-222 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days | Other | LN-OS-22 |
| Maltodextrin2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days | Other | Maltodextrin |
Primary outcome
Oxidative stress
Time frame: days 0, day 28, and day 56.
To measure the oxidative stress 8-iso-PGF2α which is considered the best biomarker of oxidative stress will be assessed in the serum of the participants enrolled in the study. The blood sample will then be sent to the laboratory for analysis of serum levels of 8-iso-PGF2α by sandwich ELISA technique using GENLISATM ELISA kits. The normal reference range of 8-iso-PGF2α is 2-34 pg/ml (median). oxidative stress as assessed by change in serum levels of 8-isoprostane
5 secondary outcomes
Systemic inflammation CRP and IL - 6
Time frame: days 0, day 28, and day 56.
Metabolic endotoxemia
Time frame: days 0, and day 56.
Body weight
Time frame: days 0, day 28, and day 56.
Waist circumference
Time frame: days 0, day 28, and day 56.
Impact of Weight on Quality of Life-Lite-Clinical Trials
Time frame: days 0, day 28, and day 56.
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 6 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Dr Shalini Srivastava, MD medicine study director
Vedic Lifesciences Pvt. Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LN-OS-22 and Maltodextrin in people with Oxidative Stress, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
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 10 inclusion and 17 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 6 Apr 2023. 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 India. 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?
Oxidative stress (time frame: days 0, day 28, and day 56.). 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 6 Apr 2023.