PrediabetesPhase 1/2PREDOPPNCT02532088
Modulating Effects of Oil Palm Phenolics in Subjects With Pre-diabetes
A Phase 1/2 study testing Oil Palm Phenolics in people with Prediabetes, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in this spontaneous diabetes model. The present study aims to determine the beneficial effects of Oil Palm Phenolics in subjects with pre-diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Oil Palm Phenolics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMalaysia
- Study dates
- May 2020to Sep 2021
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with "pre-diabetes", i.e. fasting plasma glucose level of more than 5.6 mmol/L and less than 7.0 mmol/L; or 2-hr plasma glucose load level of more than 7.8 mmol/L and less than 11.0 mmol/L.
- Subjects or his/her legally acceptable representative is willing to provide written informed consent.
Who cannot join
- Subject with terminal cancer.
- Subject with renal failure (serum creatinine more than 200 umol/L).
- Subject with significant liver impairment (liver function test of 5 times more than the upper limit level).
- Subject with severe dementia and psychosis.
- Subject requires of long term corticosteroid treatment for the underlying disease such as connective tissue disorder.
- Subject with hemoglobinopathy or anemia.
Show all 12Show fewer
- Subject underwent splenectomy or suffered from splenomegaly.
- Subject with pre-existing cardiovascular disease.
- Subject with chronic substance abuse such as chronic alcoholism or chronic opiate usage.
- Female subject of childbearing potential unless subject underwent bilateral tubal ligation, bilateral oophorectomy or hysterectomy previously.
- Subject with other significant uncontrolled medical illnesses that may interfere with drug administration or interpretation of results.
- Subject who have been included in any other clinical trial within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in this spontaneous diabetes model. The present study aims to determine the beneficial effects of Oil Palm Phenolics in subjects with pre-diabetes.
Read the detailed description
Recent studies suggest the potential of polyphenols as a supplementary treatment to delay or prevent the onset of diabetes owing to their biological properties. Polyphenols are natural phytochemical compounds found in fruits and vegetables. The most common group of phenolic compounds in our diet are phenolic acids and flavonoids. The two main classes are hydroxybenzoic acid derivatives and hydroxycinnamic acid derivatives. The anti-hyperglycemic property of polyphenols is mainly contributed by the reduction of dietary carbohydrate absorption through intestines, improvement of β-cell function and insulin action, stimulation of insulin secretion, modulation of the enzymes involved in glucose metabolism, anti-oxidative and anti-inflammatory effects.
The key enzymes responsible for the digestion of dietary carbohydrates to glucose are α-glucosidase and α-amylase. One of the most well-known properties of polyphenols especially phenolic acids on carbohydrate metabolism is the inhibition of these enzymes. Some investigations have shown that polyphenols are also able to regulate postprandial glycemia and inhibit the development of glucose intolerance by a facilitated insulin response and increased secretion of glucose-dependent insulinotropic polypeptide (GIP) and glucagonlike polypeptide-1 (GLP-1). In addition, polyphenols are able to regulate the key pathways involved in carbohydrate metabolism and hepatic glucose homeostasis. These include glycolysis, glycogenesis and gluconeogenesis, which are usually impaired in diabetes.
The current study focuses on the glucose-controlling properties of phenolic compounds extracted from oil palm (Elaeis guineensis), a high oil-producing tropical plant that also rich in phytochemicals. The major phenolic components in OPP are identified as caffeoylshikimic acid, protocatechuic acid and p-hydroxybenzoic acid. OPP has been found to exert various positive health effects parallel to the well-established physiological benefits of polyphenols. It has been shown that OPP protects against early type 2 diabetes and encouraging results suggest its role in modulating the development of diabetes. The current study aims to investigate and determine the effects of oil palm phenolics (OPP) on the blood glucose control in pre-diabetics.
- Conditions
- Prediabetes
- Being tested
- Oil Palm Phenolics, Placebo
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oil Palm PhenolicsDietary supplement
Palm fruit derived phenolics compound
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Oil Palm Phenolics | Active comparator | 500 mg gallic acid equivalent (GAE), twice daily, 12 months Receives: Dietary Supplement: Oil Palm Phenolics |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Level
- Serum Glycosylated Haemogoblin (<5.7% indicates healthy, 5.7% - 6.4% indicates prediabetes, >6.5% indicates diabetes)
- Plasma glucose level of oral glucose tolerance test (<7.8 mmol/L indicates healthy, 7.8 mmol/L - 11 mmol/L indicates prediabetes, >11 mmol/L indicates diabetes)
- Fasting plasma glucose level (<5.6 mmol/L indicates healthy, 5.6 mmol/L - 6.9 mmol/L indicates prediabetes, >6.9 mmol/L indicates diabetes)
Measured: 12 months
Secondary outcomes (4)
Insulin Sensitivity
Model-derived Oral Glucose Insulin Sensitivity (OGIS) Index will be calculated using weight (kg), height (cm), glucose (mmol/L) and insulin (pmol/L).
Measured: 12 months
Lipid profile
Total cholesterol, Low-density lipoprotein, High-density lipoprotein, Triglycerides
Measured: 12 months
Global Assessment of Efficacy
Very good, good, no change, unsatisfactory and very unsatisfactory
Measured: 12 months
Beta Cell Function
Homeostatic Model Assessment (HOMA2-B) to determine beta cell function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startMay 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Project terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Clinical Research Centre, Malaysia
- Responsible party
- Principal investigator, Yuen Kah Hay, Universiti Sains Malaysia
- Investigators
- Kah Hay Yuen, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532088
- Sponsor's protocol ID
- PREDOPP-21100
- Acronym
- PREDOPP
- Status last verified
- Sep 2021
- First submitted
- 10 Aug 2015
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Effects of Oil Palm Phenolics in Subjects With Pre-diabetes
- ClinicalTrials.gov ID
- NCT02532088
- Acronym / sponsor ID
- PREDOPP / PREDOPP-21100
- Conditions
- Prediabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Clinical Research Centre, Malaysia
- Study start
- May 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 25 Aug 2015 (estimated)
- 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.
Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in this spontaneous diabetes model. The present study aims to determine the beneficial effects of Oil Palm Phenolics in subjects with pre-diabetes.
Detailed description
Recent studies suggest the potential of polyphenols as a supplementary treatment to delay or prevent the onset of diabetes owing to their biological properties. Polyphenols are natural phytochemical compounds found in fruits and vegetables. The most common group of phenolic compounds in our diet are phenolic acids and flavonoids. The two main classes are hydroxybenzoic acid derivatives and hydroxycinnamic acid derivatives. The anti-hyperglycemic property of polyphenols is mainly contributed by the reduction of dietary carbohydrate absorption through intestines, improvement of β-cell function and insulin action, stimulation of insulin secretion, modulation of the enzymes involved in glucose metabolism, anti-oxidative and anti-inflammatory effects.
The key enzymes responsible for the digestion of dietary carbohydrates to glucose are α-glucosidase and α-amylase. One of the most well-known properties of polyphenols especially phenolic acids on carbohydrate metabolism is the inhibition of these enzymes. Some investigations have shown that polyphenols are also able to regulate postprandial glycemia and inhibit the development of glucose intolerance by a facilitated insulin response and increased secretion of glucose-dependent insulinotropic polypeptide (GIP) and glucagonlike polypeptide-1 (GLP-1). In addition, polyphenols are able to regulate the key pathways involved in carbohydrate metabolism and hepatic glucose homeostasis. These include glycolysis, glycogenesis and gluconeogenesis, which are usually impaired in diabetes.
The current study focuses on the glucose-controlling properties of phenolic compounds extracted from oil palm (Elaeis guineensis), a high oil-producing tropical plant that also rich in phytochemicals. The major phenolic components in OPP are identified as caffeoylshikimic acid, protocatechuic acid and p-hydroxybenzoic acid. OPP has been found to exert various positive health effects parallel to the well-established physiological benefits of polyphenols. It has been shown that OPP protects against early type 2 diabetes and encouraging results suggest its role in modulating the development of diabetes. The current study aims to investigate and determine the effects of oil palm phenolics (OPP) on the blood glucose control in pre-diabetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oil Palm Phenolics | Active comparator | Dietary Supplement: Oil Palm Phenolics500 mg gallic acid equivalent (GAE), twice daily, 12 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject with "pre-diabetes", i.e. fasting plasma glucose level of more than 5.6 mmol/L and less than 7.0 mmol/L; or 2-hr plasma glucose load level of more than 7.8 mmol/L and less than 11.0 mmol/L.
- Subjects or his/her legally acceptable representative is willing to provide written informed consent.
Key exclusion criteria (12 listed)
- Subject with terminal cancer.
- Subject with renal failure (serum creatinine more than 200 umol/L).
- Subject with significant liver impairment (liver function test of 5 times more than the upper limit level).
- Subject with severe dementia and psychosis.
- Subject requires of long term corticosteroid treatment for the underlying disease such as connective tissue disorder.
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 |
|---|---|---|
| Oil Palm PhenolicsPalm fruit derived phenolics compound | Dietary supplement | Oil Palm Phenolics |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Blood Glucose Level
Time frame: 12 months
1. Serum Glycosylated Haemogoblin (<5.7% indicates healthy, 5.7% - 6.4% indicates prediabetes, >6.5% indicates diabetes) 2. Plasma glucose level of oral glucose tolerance test (<7.8 mmol/L indicates healthy, 7.8 mmol/L - 11 mmol/L indicates prediabetes, >11 mmol/L indicates diabetes) 3. Fasting plasma glucose level (<5.6 mmol/L indicates healthy, 5.6 mmol/L - 6.9 mmol/L indicates prediabetes, >6.9 mmol/L indicates diabetes)
4 secondary outcomes
Insulin Sensitivity
Time frame: 12 months
Lipid profile
Time frame: 12 months
Global Assessment of Efficacy
Time frame: 12 months
Beta Cell Function
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Kah Hay Yuen, PhD principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oil Palm Phenolics in people with Prediabetes, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 2 inclusion and 12 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: withdrawn, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood Glucose Level (time frame: 12 months). 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 Oct 2021.