Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05037591 |
| Other study ID # |
7171011P321452021061500018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
September 15, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
State Islamic University of Sunan Kalijaga Yogyakarta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
- Glucose (50 -100 mg / dl)
- Protein (7.5 - 15 mg / dl)
- pH (5-9)
- Leukocytes (9-15 leu / ul)
- Nitrite (0.05-0.1 mg/ dl)
- Urobilinogen (0.2-1.0 mg / dl)
- Blood (5-10 Ery/ul)
- Ketones (2.5-5 mg/dl)
- Bilirubin (0.4-1.0 mg/ dl)
- Specific Gravity (SG) (1,000-1,030) Test the urine parameters above using Urinalysis 10U
Reagent Strips Verify (REF U031-102 exp. 2022-03-05). Pulse rate and blood pressure are
measured on each visit after a 5-minute break using intelliVue MP70 (Philips,
Netherlands). Personal reports are also recorded at these times. We kept the subjects
maintaining their usual diet and activity, and all participants completed diet records
on each visit to the clinic during the intervention period to evaluate their energy
intake and diet quality. Food intake data were analyzed by a nutritionist (Melvin Junior
Tanner, S.Gz).
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.
