An Early Phase 1 interventional study of Sea grapes extract 1.68 g/70kg BW and Placebo in Obesity, Aging and Diabetes, sponsored by State Islamic University of Sunan Kalijaga Yogyakarta. Completed at 1 site in Indonesia. Open to male participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by State Islamic University of Sunan Kalijaga Yogyakarta · Early Phase 1, Interventional, and Treatment
Doses of 150 mg/kg BW (30 mg/200g BW) sea grape extract in a previous pre-clinical trial, showed that it could improve blood glucose, total cholesterol and serum PGC-1 levels in rats fed a diet high in fat and cholesterol. In addition, you also have hepatoprotective activity (aka non-toxic) in diabetic mice. Previous research, is an in vivo (Pre-clinical) study that has not represented the benefits or efficacy of sea grape extract on variables tested in humans. Therefore, this clinical trial was conducted to support the effect of sea grape extract-antioxidant on blood glucose, total cholesterol, and PGC-1 levels in obese men for 4 weeks using a Randomized-Double Blind Controlled Trial.
The study was a 4-week, randomized, double-blind, placebo-controlled clinical trial followed by a 1-week screening period. Participants who respond to the invitation and meet the entry criteria during the telephone screening interview are scheduled for the initial visit. Evaluation during the initial visit includes physical examination in the form of BMI (Body Mass Index) based on Asia-Pacific guidelines and blood parameter screening tests in the form of blood glucose, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and total cholesterol, and PGC-1α were performed on all participants within 1 week of the initial screening. A random number between 1 and 70 was generated for each subject and registered participants were scheduled for their first visit and randomly assigned to the sea grape extract group (n=35) or placebo (n=35). Sea grape extract/placebo tablets/capsules were given to participants every 1 week (1 day of consumption per oral) 15 Minutes before eating (According to the diabetes drug guidline consumtion).
During the 4-week intervention period, participants were asked to continue their usual diet and not to consume functional foods or other dietary supplements. Anthropometry (BMI), Waist Hip Ratio (WHR) , blood parameters, urine profile (Marker of toxicity), and nutrient intake of both groups were measured before and after the intervention period. During the trial phase, all participants were instructed to maintain their normal diet and physical activity. Each week participants were asked to report assessments of side effects or changes in training, lifestyle, or diet; and to evaluate tablet compliance.
Subjects/Participants The study participants were recruited during 2021 at Manado, Republic of Indonesia. A total of 150 participants agreed to participate in the study. Only individuals men who are obese (BMI ≥ 25 kg m-2 and Waist Hip Ratio (WHR) ≥ 0.90) according to Asia-Pacific guidelines and have not been diagnosed with other diseases were included in the study. To meet guidelines for evaluating the efficacy of functional food referring to the Korea Food and Drug Administration (because Indonesia does not yet exist and Koreas belong to one Asian region so used), very obese participants (BMI ≥ 30 kg m-2) were not included in the study.
In total, 70 participants met the research criteria (age 29.98 ± 3.26 year; weight, ..... ± .... kg; BMI, .... ±.... kg m-2) and were randomly divided into two groups (n = 35 each) given sea grape extract 1.68 g/70kg BB day-1) or placebo (1.68 g/70kg BB day-1). The exclusion criteria for this study are as follows: (a) significant weight variation (over 10%) in the last 3 months; (b) a history of cardiovascular disease including arrhythmia, heart failure, or myocardial infarction, diabetes mellitus (DM) and the use of pacemakers; (c) a history of conditions that may interfere with test products or inhibit their absorption such as gastrointestinal diseases (Crohn's disease) or surgeries that have been experienced (caesarean section or enterocele); (d) participation in other clinical trials in the last 2 months; (e) abnormal liver function; (f) a history of kidney disease (eg, acute or chronic renal failure and nephrtic syndrome); (g) undergo antipsychotic drug therapy within the last 2 months; (h) laboratory test results as well as medical or psychological conditions that may interfere with successful participation in research assessed by researchers; (i) a history of alcohol or substance abuse; and (j) allergy or hypersensitivity to any of the ingredients in the test product; (k) is neither a passive nor an active smoker. All participants give written consent before the investigation begins. The research protocol was submitted to the Health Research Ethics Commission (KEPK) of The General Hospital of Education Prof. Dr. RD. Kandou (Manado, Republic of Indonesia) online at http://sim-epk.keppkn.kemkes.go.id. All protocols referred to The Declaration of Helsinki and The Council for International Organizations of Medical Sciences (CIOMS).
Measurement of Efficacy Results A total of 70 participants who met the research criteria were asked to visit the clinic once every 1 week (0th, 1st, 2nd, 3rd, and 4th/last week of the study period) with a total of 5 clinical visits including initial examination. During each visit, the use of the supplement is currently reviewed and symptoms or side effects are noted. During screening visits, demographic and lifestyle information is collected (age, alcohol consumption, and smoking habits). Medical history is taken and urine turbidity tests are carried out.
The following parameters are assessed; Weight, Height, WHR and BMI during each visit. Blood samples were collected after a minimum of 12 hours of fasting during initial screening as well as in the 0, 2nd and 4th weeks of the intervention period to obtain blood glucose profiles, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and PGC-1α. Blood samples were taken from the arm vein. The arm vein to be punctured is cleaned with 70% alcohol and allowed to dry. A tourniquet is placed on the upper arm to expose and slightly accentuate the veins. The skin is stretched over the vein with the fingers of the left hand so that the vein cannot move. The skin is pierced with a needle and syringe with the right hand until the tip of the needle enters the lumen of the vein. The tourniquet is removed and slowly withdraw the syringe suction until the desired amount of blood is obtained. A 70% alcohol swab is placed over the needle and the syringe and needle are removed. The needle is removed from the syringe and the blood sample is transferred into a vacutainer tube.
Evaluation of Safety and Diet
The safety of the extract is assessed by the following procedure. Urine Test Strips 10 Verify Parameters, Parameters examined are:
Statistical Analysis Statistical analysis is performed using SPSS software, version 26 (IBM Corporation). Fixed effects include treatment groups, treatment visits, and interactions between treatment and visit groups. The value p\<0.05 is considered statistically significant.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 70 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with State Islamic University of Sunan Kalijaga Yogyakarta as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms
Drug: Placebo
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
given sea grape extract 1.68 g/70kg BB day-1 were given to this group/arms
Drug: Sea grapes extract 1.68 g/70kg BW
Contains antioxidants 45.66 ± 0.55% and Caulerpin. Sea grapes are usually consumed raw without any indication of poisoning.
placebo lactose powder (1.68 g/70kg BW day-1).
Peroxisome proliferator-activated receptor (PPAR)-γ coactivator 1 alpha (PGC-1α) Levels "change" is being assessed
Evaluate PGC-1α level in pg/dL
Time frame: Change from Baseline PGC-1α Levels at 4th weeks of the intervention period
Total Cholesterol "change" is being assessed
Evaluate total Cholesterol level in mg/dL
Time frame: Change from Baseline Total Cholesterol at 4th weeks of the intervention period
Blood Glucose "change" is being assessed
Evaluate total blood sugar level in mg/dL
Time frame: Change from Baseline Blood Glucose at 4th weeks of the intervention period
Body Mass Index (BMI)
Body Mass Index (BMI) weight and height will be combined to report BMI in kg/m\^2
Time frame: Change from Baseline Body Mass Index (BMI) at 4th weeks of the intervention period
Triglycerides
Triglycerides in mg/dL
Time frame: Change from Baseline Triglycerides Levels at 4th weeks of the intervention period
high-density lipoprotein (HDL)
high-density lipoprotein (HDL) in mg/dL
Time frame: Change from Baseline high-density lipoprotein (HDL) Levels at 4th weeks of the intervention period
low-density lipoprotein (LDL)
low-density lipoprotein (LDL) in mg/dL
Time frame: Change from Baseline low-density lipoprotein (LDL) Levels at 4th weeks of the intervention period
Body Weight
Weight in kilograms (kg)
Time frame: Change from Baseline Body Weight at 4th weeks of the intervention period
Body Height
Height in meters (M)
Time frame: Change from Baseline Body Height at 4th weeks of the intervention period
waist-to-hip ratio (WHR)
This is calculated as waist measurement divided by hip measurement (W⁄H). For example, a person with a 30" (76 cm) waist and 38" (97 cm) hips has a waist-hip ratio of about 0.78.
Time frame: Change from Baseline waist-to-hip ratio (WHR) at 4th weeks of the intervention period
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Only measurement data with anonymized names will be shared.
Supporting information: Sap, Csr
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.