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NCT04347304
Effects of Flavanol-rich Dark Chocolate Consumption on Metabolic Profiles Among Obese Adults Using Metabolomics Approach
NA trial testing Dark chocolate (20 grams) per day providing 508 mg of polyphenols in Obesity in 74 participants. Status unknown.
23 June 2022
Quick facts
| Lead sponsor | Universiti Putra Malaysia |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 74 |
| Start date | 23 March 2022 |
| Primary completion | 23 June 2022 |
| Estimated completion | 1 September 2022 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Dark chocolate (20 grams) per day providing 508 mg of polyphenols
- white chocolate (20 grams) with no polyphenols
Conditions studied
- Obesity — all drugs for Obesity →
Sponsor
Universiti Putra Malaysia — full company profile →
Who can join
Adults 18 to 45, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04347304
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04347304 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiti Putra Malaysia
- Last refreshed: 4 April 2022
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