Body WeightNCT01749852
Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults
A study testing Polyphenol-rich Dark chocolate in people with Body Weight, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- Polyphenol-rich Dark chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- BMI between 25-35
- Males and Females
- Age: 18-65 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margaret University Lab
Musselburgh, East Lothian, EH21 6UU
About this study
Official title: Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Body Weight
- Being tested
- Polyphenol-rich Dark chocolate, Placebo Dark chocolate
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol-rich Dark chocolateOther
Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks
Placebo Dark chocolateOther
Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Polyphenol-rich Dark chocolate | Experimental | Dark chocolate with 500 mg of polyphenols Receives: Other: Polyphenol-rich Dark chocolate |
| Placebo Dark chocolate | Placebo comparator | This chocolate contains little or no polyphenols Receives: Other: Placebo Dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body weight
The body weight will be measured using a digital scale
Measured: Baseline, week 6, week 12 and week 16
Secondary outcomes (3)
Change in Body Fat percentage
Measured: Baseline, week 6, week 12 and week 16
Change in Waist circumference
Measured: Baseline, week 6, week 12 and week 16
Change in urinary Cortisol-to-cortisone ratio
Measured: Baseline, week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- Barry Callebaut
- Responsible party
- Principal investigator, Grace Farhat, Queen Margaret University
- Investigators
- Emad Al-Dujaili, PhD, Study director, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749852
- Sponsor's protocol ID
- DC-BW 01
- Status last verified
- May 2013
- First submitted
- 10 Dec 2012
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polyphenol-rich Dark Chocolate on Body Weight in Overweight and Obese Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT01749852
- Acronym / sponsor ID
- DC-BW 01
- Conditions
- Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- Barry Callebaut
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenol-rich Dark chocolate | Experimental | Other: Polyphenol-rich Dark chocolateDark chocolate with 500 mg of polyphenols |
| Placebo Dark chocolate | Placebo comparator | Other: Placebo Dark chocolateThis chocolate contains little or no polyphenols |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults
- BMI between 25-35
- Males and Females
- Age: 18-65 years
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphenol-rich Dark chocolateParticipants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks | Other | Polyphenol-rich Dark chocolate |
| Placebo Dark chocolateParticipants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks | Other | Placebo Dark chocolate |
Primary outcome
Change in Body weight
Time frame: Baseline, week 6, week 12 and week 16
The body weight will be measured using a digital scale
3 secondary outcomes
Change in Body Fat percentage
Time frame: Baseline, week 6, week 12 and week 16
Change in Waist circumference
Time frame: Baseline, week 6, week 12 and week 16
Change in urinary Cortisol-to-cortisone ratio
Time frame: Baseline, week 6 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Al-Dujaili, PhD study director
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol-rich Dark chocolate in people with Body Weight, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body weight (time frame: Baseline, week 6, week 12 and week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.