Reinventing chocolate: the dark-and-sweet side of clinical trials
More and more evidence are piling up on the health benefits of dark chocolate. Cocoa is rich in flavonoids which have potent antioxidant properties. No wonder that the biggest chocolate manufacturers are scrambling to grab this opportunity to reinvent chocolate from being the number one enemy of weight watchers, diabetics and heart patients to be the next “wonder health food” or dietary supplement that might even surpass soy and omega-3`s in terms of popularity. And no wonder that people are scrambling to volunteer to participate in chocolate clinical trials, free of charge. Given below are overviews of some trials on chocolates, past, present, and future.
Successful trials whose results have been published: [1,2]
This “randomized, controlled, investigator-blinded, parallel-group trial” investigated the effect of chocolate consumption (6.3 g of dark chocolate per day = 30 kcal) on the blood pressure of prehypertensive adults. “From baseline to 18 weeks, dark-chocolate intake reduced mean systolic BP by 2.9 mm Hg (p<0.001) and diastolic BP by 1.9 mm Hg (p<0.001) without changes in body weight, lipids, glucose, or 8-isoprostane. Hypertension prevalence decreased from 86% to 68%.”
In this double-blind randomized study, Swiss researchers at the Zurich University Hospital studied the effect of dark chocolate in 22 heart transplant patients. An intake of 40 g of dark chocolate (70% cocoa) “induces coronary vasodilation, improves coronary vascular function, and decreases platelet adhesion 2 hours after consumption. These immediate beneficial effects were paralleled by a significant reduction of serum oxidative stress and were positively correlated with changes in serum epicatechin concentration.”
The not so-successful: [3]
The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed as a double-blinded clinical trial “to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness.” However, data analysis somehow went awry because “many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial.”
This one is ongoing:
The Phase I trial on the “Effects of Dark Chocolate on Insulin Sensitivity in People with High Blood Pressure” (ClinicalTrials.gov Identifier: NCT00099476) examines “whether dark chocolate affects the way patients with hypertension (high blood pressure) respond to insulin, a hormone secreted by the pancreas that regulates blood glucose (sugar) levels. In many people with hypertension, insulin is not as effective in helping the body use glucose. This is called insulin resistance. Insulin also increases blood flow into muscle by opening inactive blood vessels. Laboratory studies suggest that eating dark chocolate may improve blood pressure. This study will determine whether dark chocolate improves insulin resistance or changes how blood vessels react to insulin in hypertensive people.”
This one is still recruiting:
This trial, due to start in June, will investigate whether flavonoids found in chocolate and other foods can reduce the risk of cardiovascular diseases in menopausal women with type 2 diabetes. “The study is funded by … Diabetes UK, and is led by a team at the University of East Anglia (UEA) in Norwich, partnered by the Elsie Bertram Diabetes Centre, Norfolk, Norwich University Hospital (NNUH) and the Institute of Food Research (IFR).”
References:
1. Taubert D, Roesen R, Lehmann C, et al. Effects of low habitual cocoa intake on blood pressure and bioactive nitric oxide. A randomized controlled trial. JAMA 2007; 298:49-60
2. Flammer A, Hermann F, Sudano I, et al. Dark chocolate improves coronary vasomotion and reduces platelet reactivity. Circulation 2007;116:2376-2382.
3. Chan, K. A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study. CMAJ 2007; 177 (12).
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