NCT04347304

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

April 7, 2020

Last Update Submit

March 23, 2022

Conditions

Obesity

Keywords

ObesityCocoa polyphenolsDark chocolate

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    baseline and 8 weeks

Secondary Outcomes (7)

  • change in body weight at 8 weeks

    baseline and 8 weeks

  • change in waist circumference at 8 weeks

    baseline and 8 weeks

  • change in lipid profiles (TG, HDL-c, LDL-c, TC) at 8 weeks

    baseline and 8 weeks

  • change in inflammatory markers (C-reactive protein ) at 8 week

    baseline and 8 weeks

  • change in oxidative stress markers (oxidized LDL) at 8 week

    baseline and 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

cocoa polyphenols

EXPERIMENTAL

21 grams of dark chocolate (289 mg polyphenols)

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)

Dietary Supplement: white chocolate (20 grams) with no polyphenols

Interventions

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.

cocoa polyphenols
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

polyphenols free

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Putra Malaysia

Seri Kembangan, Selangor, 43400, Malaysia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23088297BACKGROUND

  • 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.

    PMID: 10927169BACKGROUND

  • 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.

    PMID: 21085649BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Polyphenols

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Amin Ismail, PhD

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zulfitri Azuan Mat Daud, PhD

CONTACT

+60397692431zulfitri@upm.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 15, 2020

Study Start

March 23, 2022

Primary Completion

June 23, 2022

Study Completion

September 1, 2022

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations

MY(1)