Effects of Flavanol-rich Dark Chocolate Consumption on Metabolic Profiles Among Obese Adults Using Metabolomics Approach

NCT ID: NCT04347304

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2022-09-01

Brief 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 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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cocoa polyphenols

21 grams of dark chocolate (289 mg polyphenols)

Group Type: EXPERIMENTAL

Dark chocolate (20 grams) per day providing 508 mg of polyphenols

Intervention Type: DIETARY_SUPPLEMENT

subjects will be given 21 grams of dark chocolate providing 289 mg of polyphenols per day for 12 weeks.

polyphenols free

21 grams of white chocolate (0 mg polyphenols)

Group Type: PLACEBO_COMPARATOR

white chocolate (20 grams) with no polyphenols

Intervention Type: DIETARY_SUPPLEMENT

subjects will be given 21 grams of white chocolate (0 mg polyohenols) per day for 12 weeks

Interventions

Dark chocolate (20 grams) per day providing 508 mg of polyphenols

subjects will be given 21 grams of dark chocolate providing 289 mg of polyphenols per day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

white chocolate (20 grams) with no polyphenols

subjects will be given 21 grams of white chocolate (0 mg polyohenols) per day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Hasmiza Halib

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amin Ismail, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Locations

Universiti Putra Malaysia

Seri Kembangan, Selangor, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Zulfitri Azuan Mat Daud, PhD

Role: CONTACT

zulfitri@upm.edu.my

+60397692431

Facility Contacts

Zulfitri Azuan Mat Daud, PhD

Role: primary

zulfitri@upm.edu.my

60397692431

References

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.

Reference Type: BACKGROUND

PMID: 23088297 (View on PubMed)

Hensley 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.

Reference Type: BACKGROUND

PMID: 10927169 (View on PubMed)

Suhre 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.

Reference Type: BACKGROUND

PMID: 21085649 (View on PubMed)

Other Identifiers

NMRR-19-3092-51617.

Identifier Type: -

Identifier Source: org_study_id