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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
64
2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days
2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days
Ayush Nursing Home
Mumbai, Maharashtra, India
Dr. Awate's Clinic
Mumbai, Maharashtra, India
Metabol-Lifestyle metabolic syndrome clinic
Mumbai, Maharashtra, India
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
Time frame: days 0, day 28, and day 56.
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: days 0, day 28, and day 56.
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