ObesityNCT04347304
Effects of Flavanol-rich Dark Chocolate Consumption on Metabolic Profiles Among Obese Adults Using Metabolomics Approach
A study testing Dark chocolate (20 grams) per day providing 508 mg of polyphenols and white chocolate (20 grams) with no polyphenols in people with Obesity, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
Obesity has become a global issue due to its alarming high and increasing prevalence worldwide and the roles it plays in occurrence of many chronic diseases. In addition, obesity is characterized as a state of chronic, low-grade inflammation and is associated with an abnormal inflammatory response, low antioxidant… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dark chocolate (20 grams) per day providing 508 mg of polyphenols and white chocolate (20 grams) with no polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Mar 2022to 1 Sep 2022
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysian
- Obese BMI ≥ 25.0 kg/m2
- Not on any drug or herbal preparation, antioxidative or any drugs or dietary supplement.
- Do not have any chronic diseases
- Do not have allergy to cocoa
- Age 18-45 years old.
Who cannot join
- Non-Malaysian
- BMI < 25.0 kg/m2
- Smokers and alcohol drinkers
- Participants with cardiovascular diseases, hypertension or diabetes
- Participants taking medications that affect insulin, glucose, lipid or blood pressure levels
- Participants taking any dietary supplements
- Have allergy towards cocoa beverages
- Participants who are currently involved in a weight management program
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Putra Malaysia
Seri Kembangan, Selangor, 43400
Zulfitri Azuan Mat Daud, PhD, 60397692431, zulfitri@upm.edu.my
About this study
Official title: Effects of Flavanol-rich Dark Chocolate Consumption on Metabolic Profiles Among Obese
Obesity has become a global issue due to its alarming high and increasing prevalence worldwide and the roles it plays in occurrence of many chronic diseases. In addition, obesity is characterized as a state of chronic, low-grade inflammation and is associated with an abnormal inflammatory response, low antioxidant capacity and reduced insulin sensitivity which lead to the generation of inflammation, oxidative stress and insulin resistance.
As in Malaysia, study by National Health and Morbidity Survey Malaysia (NHMS) in 2011 and 2015 showed a continuing increase of the problem. In response to the rise of obesity prevalence, various efforts and strategies have been implemented in the past decade to combat this problem. The use of natural products as therapeutic agents in preventing metabolic disease has becoming popular. Cocoa and its products is a largely consumed food in the world. It has a very rich sources of phenolic compound. Several in vitro and in vivo studies have shown that polyphenols, with antioxidant, anti-inflammatory and anti-obesity properties, can boost energy expenditure and thermogenesis, lessen oxidative stress and inflammation while supporting weight loss management. Furthermore, the contribution of human studies especially among obese relatively limited.
The popularity of chocolate and/or cocoa and its frequent consumption made it the target of many research studies, due to its favourable effects, and to the significant role it may exert on improving the obesity condition. Therefore, this study aims to investigate the effects of flavanol-rich dark chocolate consumption on metabolic profiles of obese adults using metabolomic approach.
Read the detailed description
Overnutrition and sedentary lifestyle are the leading factors associated with the development of obesity. Obese adults usually are advised to make lifestyle modifications which include dietary restriction and physical activity recommendation. In addition, dietary supplements and medication such as anti-hypertensive, lipid lowering drugs are used to achieved targeted body weight of obese adult. Therefore, the confounding factors in this study namely dietary intake, physical activity, medication, supplements were controlled throughout the study. These factors including smoking were also controlled as it will affect the metabolites.
Imbalance between energy intake and expenditure results in adipose tissue expansion due to excessive lipogenesis in adipose tissues. Generally, it is well accepted that adipose tissue expansion in an obese state is accompanied by elevated inflammation. Oxidative stress and pro-inflammatory processes are strongly related. Increased abdominal adipose tissue accelerates the production of pro-inflammatory cytokines which promote increased generation of ROS, both inflammation and oxidative stress play a significant role in the development of insulin resistant thus further are associated with the degree of metabolic dysfunction.
It was hypothesized that cocoa flavanol with the properties of anti-inflammation, anti-oxidative and antiobesity properties may reduce the oxidative stress and inflammation, subsequently reduce the insulin resistance and thus improved the outcome measurements in obese adult. In order to measures the altered metabolite in the urine and blood serum following cocoa rich flavanol consumption in dark chocolate in obese adult, a metabolomics based approach is used in this study.
This study is a randomized, open-labelled, parallel controlled trial where the intervention group will receive 20 grams of dark chocolate, daily for 12 weeks while the control group will receive 20 grams of white chocolate daily for 12 weeks. Measurement will be taken including sociodemographic, anthropometric measurement, diet and physical activity questionnaire, blood and urine samples at baseline and 12 weeks of intervention. Obese male adult aged 18-45 years old will be recruited
- Conditions
- Obesity
- Being tested
- Dark chocolate (20 grams) per day providing 508 mg of polyphenols, white chocolate (20 grams) with no polyphenols
- Keywords
- Obesity, Cocoa polyphenols, Dark chocolate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark chocolate (20 grams) per day providing 508 mg of polyphenolsDietary supplement
subjects will be given 21 grams of dark chocolate providing 289 mg of polyphenols per day for 12 weeks.
white chocolate (20 grams) with no polyphenolsDietary supplement
subjects will be given 21 grams of white chocolate (0 mg polyohenols) per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| cocoa polyphenols | Experimental | 21 grams of dark chocolate (289 mg polyphenols) Receives: Dietary Supplement: Dark chocolate (20 grams) per day providing 508 mg of polyphenols |
| polyphenols free | Placebo comparator | 21 grams of white chocolate (0 mg polyphenols) Receives: Dietary Supplement: white chocolate (20 grams) with no polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in insulin resistance at 12 week
Insulin resistance will be determined HOMA-IR and calculated as HOMA-IR = fasting serum x fasting blood glucose/22.5.
Measured: baseline and 8 weeks
change in insulin sensitivity at 8 weeks
To assess insulin sensitivity, Quantitative Insulin Sensitivity Check Index (QUICKI) will be used and cutt off point of less than 0.33 indicates reduced insulin sensitivity
Measured: baseline and 8 weeks
Secondary outcomes (7)
change in body weight at 8 weeks
Body weight will be measured in kilograms using SECA electronic scale model 703.
Measured: baseline and 8 weeks
change in waist circumference at 8 weeks
Waist circumference will be assessed at the midpoint between the lowest rib andd the iliac crest using a non-stretchable tape measure. The measurement will be conducted twice to the nearest 0.1cm. The cutoff points for waist ciircumference by WHO expert committee on obesity in Asian and Pacific populations are >90 cm for men and >80cm fro women.
Measured: baseline and 8 weeks
change in lipid profiles (TG, HDL-c, LDL-c, TC) at 8 weeks
Lipid profiles (TG, Cholesterol, LDL-c, and HDL-c) will be determined using commercially available kits using Architect ci8200 analyzer
Measured: baseline and 8 weeks
change in inflammatory markers (C-reactive protein ) at 8 week
C-reactive protein will be measured using kits of human inflammatory cytokines by Enzyme Linked Inmuno Sorbent Assay from blood serum and will be expressed as mg/L.
Measured: baseline and 8 weeks
change in oxidative stress markers (oxidized LDL) at 8 week
Levels of LDL-ox in plasma will be analysed at the beginning and the end (8 weeks) and will be expressed as mg/L.
Measured: baseline and 8 weeks
changes in metabolomics profiles following flavanol-rich dark chocolate consumption at 8 week
Metabolomic analysis of the plasma sample will be performed using 1H-NMR platform
Measured: baseline and 8 weeks
changes in gut microbiome status following flavanol-rich dark chocolate consumption at 8 week
metagenomic analysis of fecal samples will be analysed at the beginning and end (8 weeks)
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start23 Mar 2022 (estimated)
- Primary completion23 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, open-labelled, parallel controlled trial will be conducted in Universiti Putra Malaysia from October 2021 until December 2022 involving obese adult aged 18 - 45 years.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasmiza Halib, Universiti Putra Malaysia
- Investigators
- Amin Ismail, PhD, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347304
- Sponsor's protocol ID
- NMRR-19-3092-51617.
- Status last verified
- Mar 2022
- First submitted
- 7 Apr 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moazzami AA, Bondia-Pons I, Hanhineva K, Juntunen K, Antl N, Poutanen K, Mykkanen H. Metabolomics reveals the metabolic shifts following an intervention with rye bread in postmenopausal women--a randomized control trial. Nutr J. 2012 Oct 22;11:88. doi: 10.1186/1475-2891-11-88.
PubMed 23088297Hensley K, Robinson KA, Gabbita SP, Salsman S, Floyd RA. Reactive oxygen species, cell signaling, and cell injury. Free Radic Biol Med. 2000 May 15;28(10):1456-62. doi: 10.1016/s0891-5849(00)00252-5.
PubMed 10927169Suhre K, Meisinger C, Doring A, Altmaier E, Belcredi P, Gieger C, Chang D, Milburn MV, Gall WE, Weinberger KM, Mewes HW, Hrabe de Angelis M, Wichmann HE, Kronenberg F, Adamski J, Illig T. Metabolic footprint of diabetes: a multiplatform metabolomics study in an epidemiological setting. PLoS One. 2010 Nov 11;5(11):e13953. doi: 10.1371/journal.pone.0013953.
PubMed 21085649
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flavanol-rich Dark Chocolate Consumption on Metabolic Profiles Among Obese
- ClinicalTrials.gov ID
- NCT04347304
- Acronym / sponsor ID
- NMRR-19-3092-51617.
- Conditions
- Obesity
- Keywords
- Obesity, Cocoa polyphenols, Dark chocolate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 23 Mar 2022 (estimated)
- Primary completion
- 23 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 15 Apr 2020 (actual)
- 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.
Obesity has become a global issue due to its alarming high and increasing prevalence worldwide and the roles it plays in occurrence of many chronic diseases. In addition, obesity is characterized as a state of chronic, low-grade inflammation and is associated with an abnormal inflammatory response, low antioxidant capacity and reduced insulin sensitivity which lead to the generation of inflammation, oxidative stress and insulin resistance.
As in Malaysia, study by National Health and Morbidity Survey Malaysia (NHMS) in 2011 and 2015 showed a continuing increase of the problem. In response to the rise of obesity prevalence, various efforts and strategies have been implemented in the past decade to combat this problem. The use of natural products as therapeutic agents in preventing metabolic disease has becoming popular. Cocoa and its products is a largely consumed food in the world. It has a very rich sources of phenolic compound. Several in vitro and in vivo studies have shown that polyphenols, with antioxidant, anti-inflammatory and anti-obesity properties, can boost energy expenditure and thermogenesis, lessen oxidative stress and inflammation while supporting weight loss management. Furthermore, the contribution of human studies especially among obese relatively limited.
The popularity of chocolate and/or cocoa and its frequent consumption made it the target of many research studies, due to its favourable effects, and to the significant role it may exert on improving the obesity condition. Therefore, this study aims to investigate the effects of flavanol-rich dark chocolate consumption on metabolic profiles of obese adults using metabolomic approach.
Detailed description
Overnutrition and sedentary lifestyle are the leading factors associated with the development of obesity. Obese adults usually are advised to make lifestyle modifications which include dietary restriction and physical activity recommendation. In addition, dietary supplements and medication such as anti-hypertensive, lipid lowering drugs are used to achieved targeted body weight of obese adult. Therefore, the confounding factors in this study namely dietary intake, physical activity, medication, supplements were controlled throughout the study. These factors including smoking were also controlled as it will affect the metabolites.
Imbalance between energy intake and expenditure results in adipose tissue expansion due to excessive lipogenesis in adipose tissues. Generally, it is well accepted that adipose tissue expansion in an obese state is accompanied by elevated inflammation. Oxidative stress and pro-inflammatory processes are strongly related. Increased abdominal adipose tissue accelerates the production of pro-inflammatory cytokines which promote increased generation of ROS, both inflammation and oxidative stress play a significant role in the development of insulin resistant thus further are associated with the degree of metabolic dysfunction.
It was hypothesized that cocoa flavanol with the properties of anti-inflammation, anti-oxidative and antiobesity properties may reduce the oxidative stress and inflammation, subsequently reduce the insulin resistance and thus improved the outcome measurements in obese adult. In order to measures the altered metabolite in the urine and blood serum following cocoa rich flavanol consumption in dark chocolate in obese adult, a metabolomics based approach is used in this study.
This study is a randomized, open-labelled, parallel controlled trial where the intervention group will receive 20 grams of dark chocolate, daily for 12 weeks while the control group will receive 20 grams of white chocolate daily for 12 weeks. Measurement will be taken including sociodemographic, anthropometric measurement, diet and physical activity questionnaire, blood and urine samples at baseline and 12 weeks of intervention. Obese male adult aged 18-45 years old will be recruited
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-labelled, parallel controlled trial will be conducted in Universiti Putra Malaysia from October 2021 until December 2022 involving obese adult aged 18 - 45 years.
| Arm | Type | Receives |
|---|---|---|
| cocoa polyphenols | Experimental | Dietary Supplement: Dark chocolate (20 grams) per day providing 508 mg of polyphenols21 grams of dark chocolate (289 mg polyphenols) |
| polyphenols free | Placebo comparator | Dietary Supplement: white chocolate (20 grams) with no polyphenols21 grams of white chocolate (0 mg polyphenols) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Malaysian
- Obese BMI ≥ 25.0 kg/m2
- Not on any drug or herbal preparation, antioxidative or any drugs or dietary supplement.
- Do not have any chronic diseases
- Do not have allergy to cocoa
Key exclusion criteria (8 listed)
- Non-Malaysian
- BMI < 25.0 kg/m2
- Smokers and alcohol drinkers
- Participants with cardiovascular diseases, hypertension or diabetes
- Participants taking medications that affect insulin, glucose, lipid or blood pressure levels
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 |
|---|---|---|
| Dark chocolate (20 grams) per day providing 508 mg of polyphenolssubjects will be given 21 grams of dark chocolate providing 289 mg of polyphenols per day for 12 weeks. | Dietary supplement | cocoa polyphenols |
| white chocolate (20 grams) with no polyphenolssubjects will be given 21 grams of white chocolate (0 mg polyohenols) per day for 12 weeks | Dietary supplement | polyphenols free |
Primary outcome
change in insulin resistance at 12 week
Time frame: baseline and 8 weeks
Insulin resistance will be determined HOMA-IR and calculated as HOMA-IR = fasting serum x fasting blood glucose/22.5.
change in insulin sensitivity at 8 weeks
Time frame: baseline and 8 weeks
To assess insulin sensitivity, Quantitative Insulin Sensitivity Check Index (QUICKI) will be used and cutt off point of less than 0.33 indicates reduced insulin sensitivity
7 secondary outcomes
change in body weight at 8 weeks
Time frame: baseline and 8 weeks
change in waist circumference at 8 weeks
Time frame: baseline and 8 weeks
change in lipid profiles (TG, HDL-c, LDL-c, TC) at 8 weeks
Time frame: baseline and 8 weeks
change in inflammatory markers (C-reactive protein ) at 8 week
Time frame: baseline and 8 weeks
change in oxidative stress markers (oxidized LDL) at 8 week
Time frame: baseline and 8 weeks
changes in metabolomics profiles following flavanol-rich dark chocolate consumption at 8 week
Time frame: baseline and 8 weeks
changes in gut microbiome status following flavanol-rich dark chocolate consumption at 8 week
Time frame: baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 23088297Moazzami AA, Bondia-Pons I, Hanhineva K, Juntunen K, Antl N, Poutanen K, Mykkanen H. Metabolomics reveals the metabolic shifts following an intervention with rye bread in postmenopausal women--a randomized control trial. Nutr J. 2012 Oct 22;11:88. doi: 10.1186/1475-2891-11-88.
- Background: PubMed 10927169Hensley K, Robinson KA, Gabbita SP, Salsman S, Floyd RA. Reactive oxygen species, cell signaling, and cell injury. Free Radic Biol Med. 2000 May 15;28(10):1456-62. doi: 10.1016/s0891-5849(00)00252-5.
- Background: PubMed 21085649Suhre K, Meisinger C, Doring A, Altmaier E, Belcredi P, Gieger C, Chang D, Milburn MV, Gall WE, Weinberger KM, Mewes HW, Hrabe de Angelis M, Wichmann HE, Kronenberg F, Adamski J, Illig T. Metabolic footprint of diabetes: a multiplatform metabolomics study in an epidemiological setting. PLoS One. 2010 Nov 11;5(11):e13953. doi: 10.1371/journal.pone.0013953.
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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.
Amin Ismail, PhD principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark chocolate (20 grams) per day providing 508 mg of polyphenols and white chocolate (20 grams) with no polyphenols in people with Obesity, run by Universiti Putra 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Apr 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zulfitri Azuan Mat Daud, PhD (+60397692431, zulfitri@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in insulin resistance at 12 week (time frame: baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347304, which also lists 3 linked publications.
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 4 Apr 2022.