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Completed

NCT Number: NCT01749852

Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults

The aim of this study is to investigate if dark chocolate rich in polyphenols decreases body weight/ body fat in the overweight and obese adult population.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Margaret University Lab

Musselburgh, East Lothian, EH21 6UU, United Kingdom

About this study

Polyphenols are phytochemicals widely available in plants, and may have several favourable effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods. Animal and in vitro studies have demonstrated that cocoa and dark chocolate may exert anti-obesity effects mainly due to the polyphenol effect on glucose and fatty acid metabolism. Human studies have showed that regular chocolate eaters have a lower body weight compared to non regular eaters, and that DC promotes satiety and reduces cravings. The aim of this pilot study is to investigate the effect of polyphenol-rich DC on body weight in the overweight and obese adult population, when incorporated into a non-restricted diet. Twenty-eight apparently healthy volunteers will be recruited. Participants will randomly receive 20g daily of one of the two different types of DC: Placebo DC (low in polyphenols) or DC rich in polyphenols (500mg) for a period of twelve weeks. Participants will be asked to make three appointments and one follow-up appointment to the university clinical lab. Anthropometric measurements (height, weight, waist circumference, body fat percentage) will be taken during each visit. Compliance will be defined by the intake of 85 % or more of the chocolate weekly, and will be tested by the measure of total polyphenols in a 24-hour urine sample before, during and at the end of the intervention. To monitor any fluctuations in the participants' diet or physical activity during the study period, a three-day diet diary, a Food Frequency questionnaire assessment for polyphenol intake and a physical activity questionnaire will be collected before the start of the study and every four weeks. A follow-up appointment (four weeks after the end of intervention) will check if any differences in anthropometric measures have been maintained. Data will be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor. This study will have novel findings and will be the basis for a future larger trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults
  • BMI between 25-35
  • Males and Females
  • Age: 18-65 years

Exclusion criteria

  • Participants with cardiovascular diseases, hypertension or diabetes
  • Participants taking any medications that affect insulin, cholesterol, triglycerides or Blood pressure
  • Participants who recently participated or are currently on a weight management program
  • Participants with regular consumption of cocoa or DC (> 1 serving/week)

Treatment and study plan

Polyphenol-rich Dark chocolate

Other

Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks

Placebo Dark chocolate

Other

Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks

Primary outcomes

  1. Change in Body weight

    Time frame: Baseline, week 6, week 12 and week 16

    The body weight will be measured using a digital scale

Secondary outcomes

  1. Change in Body Fat percentage

    Time frame: Baseline, week 6, week 12 and week 16

  2. Change in Waist circumference

    Time frame: Baseline, week 6, week 12 and week 16

  3. Change in urinary Cortisol-to-cortisone ratio

    Time frame: Baseline, week 6 and week 12

Sponsors and collaborators

Lead sponsor

Queen Margaret University

Other

Collaborators

  • Barry Callebaut

Registry information

Official study title

Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults: A Pilot Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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