Effect of Sea Grapes-antioxidants Extract in Obese Men : 4 Weeks Randomized-Double Blind Controlled Trial

NCT05037591 | Completed Early Phase 1 DMC

• 1 other identifier: 7171011P321452021061500018
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Aging; Diabetes

Keywords

Obesity; Aging; Functional Food; Diabetes; Dyslipidemia

Outcome Measures

Primary Outcomes (3)

• Peroxisome proliferator-activated receptor (PPAR)-γ coactivator 1 alpha (PGC-1α) Levels "change" is being assessed

  Evaluate PGC-1α level in pg/dL

  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

  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

  Change from Baseline Blood Glucose at 4th weeks of the intervention period

Secondary Outcomes (7)

• Body Mass Index (BMI)

  Change from Baseline Body Mass Index (BMI) at 4th weeks of the intervention period

• Triglycerides

  Change from Baseline Triglycerides Levels at 4th weeks of the intervention period

• high-density lipoprotein (HDL)

  Change from Baseline high-density lipoprotein (HDL) Levels at 4th weeks of the intervention period

• low-density lipoprotein (LDL)

  Change from Baseline low-density lipoprotein (LDL) Levels at 4th weeks of the intervention period

• Body Weight

  Change from Baseline Body Weight at 4th weeks of the intervention period

Study Arms (40)

placebo A

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo B

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo C

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo D

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo E

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo F

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo G

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo H

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo I

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo J

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo K

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo L

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo M

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo N

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo O

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo P

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo Q

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo R

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo S

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

placebo T

PLACEBO COMPARATOR

placebo lactose powder (1.68 g/70kg BW day-1) or placebo tablets were given to this group/arms

Drug: Placebo

sea grape extract A

EXPERIMENTAL

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

sea grape extract B

EXPERIMENTAL

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

sea grape extract C

EXPERIMENTAL

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

sea grape extract D

EXPERIMENTAL

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

sea grape extract E

EXPERIMENTAL

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

sea grape extract F

EXPERIMENTAL

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

sea grape extract G

EXPERIMENTAL

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

sea grape extract H

EXPERIMENTAL

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

sea grape extract I

EXPERIMENTAL

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

sea grape extract J

EXPERIMENTAL

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

sea grape extract K

EXPERIMENTAL

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

sea grape extract L

EXPERIMENTAL

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

sea grape extract M

EXPERIMENTAL

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

sea grape extract N

EXPERIMENTAL

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

sea grape extract O

EXPERIMENTAL

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

sea grape extract P

EXPERIMENTAL

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

sea grape extract Q

EXPERIMENTAL

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

sea grape extract R

EXPERIMENTAL

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

sea grape extract S

EXPERIMENTAL

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

sea grape extract T

EXPERIMENTAL

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

Interventions

Sea grapes extract 1.68 g/70kg BW DRUG

Contains antioxidants 45.66 ± 0.55% and Caulerpin. Sea grapes are usually consumed raw without any indication of poisoning.

sea grape extract A; sea grape extract B; sea grape extract C; sea grape extract D; sea grape extract E; sea grape extract F; sea grape extract G; sea grape extract H; sea grape extract I; sea grape extract J; sea grape extract K; sea grape extract L; sea grape extract M; sea grape extract N; sea grape extract O; sea grape extract P; sea grape extract Q; sea grape extract R; sea grape extract S; sea grape extract T

Placebo DRUG

placebo lactose powder (1.68 g/70kg BW day-1).

placebo A; placebo B; placebo C; placebo D; placebo E; placebo F; placebo G; placebo H; placebo I; placebo J; placebo K; placebo L; placebo M; placebo N; placebo O; placebo P; placebo Q; placebo R; placebo S; placebo T

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Only individuals men who are obese (BMI ≥ 25 kg m-2) according to Asia-Pacific guidelines
• Waist Hip Ratio (WHR) ≥ 0.90 according to Asia-Pacific guidelines and
• not been diagnosed with other diseases were included in the study.

You may not qualify if:

• (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.

Sponsors & Collaborators

• State Islamic University of Sunan Kalijaga Yogyakarta: lead

Study Sites (1)

Fahrul Nurkolis

Manado, North Sulawesi, 95115, Indonesia

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Dyslipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Study Officials

• Fahrul Nurkolis

  UIN Sunan Kalijaga Yogyakarta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study was a 4-week, randomized, double-blind, placebo-controlled clinical trial. Evaluation during the initial visit includes physical examination in the form of 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).

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 8, 2021
• Study Start: August 1, 2021
• Primary Completion: September 7, 2021
• Study Completion: September 15, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: After research
• Access Criteria: repository

Locations

ID (1)