HealthyFEDNCT02533817
Fructose and Ethnic Differences Study (FED Study)
A study testing Dietary sugar in people with Healthy, run by King's College London.
Trial summary
In the UK, people of black West African and Caribbean's tend to have healthier blood cholesterol and blood fat levels, as well as lower incidence of heart disease/heart attack. But rates of heart disease are now rising in young African-American populations with diabetes, for the first time exceeding the rate in their… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary sugar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jul 2015
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-reported healthy, confirmed by blood tests (i.e. liver enzymes, full blood count, lipids, glucose); ethnicity White European participants had at least 3 grandparents originating from countries of Europe and Black African participants had at least 3 grandparents originating primarily from countries of West Africa (Economic Community of West African States (ECOWAS) and central African countries (e.g. Cameroon, Uganda, etc).
Who cannot join
- fasting glucose in the diabetic range (fasting glucose >7 mmol/l); hypertension (medically diagnosed or >140/90 mm Hg at screening); hyperlipidaemia deemed to require immediate medical intervention (defined as: total cholesterol >6.0 mmol/l; LDL-cholesterol >4.5 mmol/l; fasting TG >3 mmol/l).
About this study
Official title: Fructose and Ethnic Differences Study
In the UK, people of black West African and Caribbean's tend to have healthier blood cholesterol and blood fat levels, as well as lower incidence of heart disease/heart attack. But rates of heart disease are now rising in young African-American populations with diabetes, for the first time exceeding the rate in their white European-American peers. One possible culprit is the increasing consumption of fructose which can lead to high blood fat levels. Fructose is a natural sugar found in fruits and table sugar but is also used the food industry as an ingredient and sweetener. Because fructose intakes are lower in the UK than in North America we are studying the effect of fructose intake in UK black West African and Caribbean people, to understand if fructose intake is indeed a reason for these ethnic differences.
Read the detailed description
The overall nature of this study is to conduct an investigation into the metabolic effects of acute high fructose versus high glucose feeding in people of Black African (BA) compared to age and BMI-matched control subjects of White-European (WE) origin . The research question of our study is: do people of BA metabolise fructose differently than people of WE when challenged with a high sugar diet? Therefore, our specific aims are to determine the following in both people of BA and WE consuming both high fructose and high glucose meals: 1) the postprandial pattern of blood insulin, glucose, triglyceride and cholesterol concentrations; 2) ambulatory blood pressure measures during the postprandial period and 4) postprandial and 0-24-hour fasted serum and red blood cell membrane cholesterol and non-cholesterol sterol concentrations.
Potential participants will attend the scheduled screening session where the requirements of participation will be described and the participants will be given an opportunity to ask any questions they may have. Those still willing to participate will sign the informed consent form before the screening assessment is performed. Screening will require a fasted blood sample to be taken as well as a brief questionnaire to ascertain ethnicity (self-declared), medications and health status. An assessment of weight, height and waist circumference will also be taken to confirm they meet the inclusion criteria. It is expected that the results of the screening blood sample will be available within 1-2 weeks. Those participants meeting the inclusion criteria will be contacted and scheduled for the first study visit. Those not meeting the criteria will be notified by their preferred means of contact, a copy of their results will be provided.
Prior to attending participants treatment order will be randomized. Participants will report to the Metabolic Research Unit (MRU) at 08.00 following an overnight fast. A catheter will be inserted into an antecubital vein for collection of blood samples and a baseline blood sample collected at this time. Participant will be asked to undertake minimal physical activity during the remainder of the study period. A breakfast meal will be given at 0min, the lunch meal at 240min and meals will be consumed within 15 minutes. Participants will be fitted with a portable continuous blood pressure and heart rate monitor (arteriograph) and instructed on what to expect as it functions. Further blood samples will be taken at -30, -15, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420min and at 24hrs (1440min, fasted). The energy content of the meals will be the estimated energy requirements of the participant (to the nearest 100kcals), with 20% of total daily energy coming from glucose or fructose. The glucose or fructose will be given dissolved water with added colour and orange/fruit flavours and provided at breakfast, lunch and supper. The remaining daily caloric requirement for each participant will be given a standardized evening meal to take away and consume at home.
- Conditions
- Healthy
- Being tested
- Dietary sugar
- Keywords
- Fructose, Insulin, Postprandial lipemia, Ambulatory blood pressure, Ethnicity
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary sugarDietary supplement
This study examined the effect of high intakes of fructose compared to high intakes of glucose in a randomized crossover design. The treatment was in replacement of 20% of the daily caloric requirements for either fructose or glucose for each individual.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Sugar - Fructose | Experimental | Each participant consumed 20% daily caloric requirement as fructose. Receives: Dietary Supplement: Dietary sugar |
| Dietary Sugar - Glucose | Active comparator | Each participant consumed 20% daily caloric requirement as glucose. Receives: Dietary Supplement: Dietary sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial triglyceride concentrations
At time 0 minutes participants were provided with a study breakfast which they were required to consume within a 15 minute period and subsequent blood samples were drawn at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 and 420 minutes. The lunch meal was consumed immediately following the 240 minute blood sample and final fructose/glucose drink was consumed immediately following the 420 minute blood sample. A final blood sample was drawn at 24 hours under fasting conditions.
Measured: 0-420 minutes
Secondary outcomes (5)
Postprandial glucose concentrations.
At time 0 minutes participants were provided with a study breakfast which they were required to consume within a 15 minute period and subsequent blood samples were drawn at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 and 420 minutes. The lunch meal was consumed immediately following the 240 minute blood sample and final fructose/glucose drink was consumed immediately following the 420 minute blood sample. A final blood sample was drawn at 24 hours under fasting conditions.
Measured: 0-420 minutes
Serum and red blood cell cholesterol and non-cholesterol sterol concentrations
Blood samples collected at 0 and 24 hours post treatment consumption for serum and red blood cell membrane cholesterol and non-cholesterol sterol concentrations.
Measured: 0 and 24-hour post treatment
Postprandial insulin concentrations
At time 0 minutes participants were provided with a study breakfast which they were required to consume within a 15 minute period and subsequent blood samples were drawn at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 and 420 minutes. The lunch meal was consumed immediately following the 240 minute blood sample and final fructose/glucose drink was consumed immediately following the 420 minute blood sample.
Measured: 0-420 minutes
Postprandial c-peptide concentrations
At time 0 minutes participants were provided with a study breakfast which they were required to consume within a 15 minute period and subsequent blood samples were drawn at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 and 420 minutes. The lunch meal was consumed immediately following the 240 minute blood sample and final fructose/glucose drink was consumed immediately following the 420 minute blood sample.
Measured: 0-420 minutes
Postprandial non-esterified fatty acid concentrations
At time 0 minutes participants were provided with a study breakfast which they were required to consume within a 15 minute period and subsequent blood samples were drawn at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 and 420 minutes. The lunch meal was consumed immediately following the 240 minute blood sample and final fructose/glucose drink was consumed immediately following the 420 minute blood sample.
Measured: 0-420 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startDec 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott V Harding, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533817
- Sponsor's protocol ID
- BDM/12/13-7
- Acronym
- FED
- Status last verified
- May 2016
- First submitted
- 30 Jul 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Goff LM, Whyte MB, Samuel M, Harding SV. Significantly greater triglyceridemia in Black African compared to White European men following high added fructose and glucose feeding: a randomized crossover trial. Lipids Health Dis. 2016 Sep 2;15(1):145. doi: 10.1186/s12944-016-0315-3.
PubMed 27590876
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose and Ethnic Differences Study
- ClinicalTrials.gov ID
- NCT02533817
- Acronym / sponsor ID
- FED / BDM/12/13-7
- Conditions
- Healthy
- Keywords
- Fructose, Insulin, Postprandial lipemia, Ambulatory blood pressure, Ethnicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Aug 2015 (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.
In the UK, people of black West African and Caribbean's tend to have healthier blood cholesterol and blood fat levels, as well as lower incidence of heart disease/heart attack. But rates of heart disease are now rising in young African-American populations with diabetes, for the first time exceeding the rate in their white European-American peers. One possible culprit is the increasing consumption of fructose which can lead to high blood fat levels. Fructose is a natural sugar found in fruits and table sugar but is also used the food industry as an ingredient and sweetener. Because fructose intakes are lower in the UK than in North America we are studying the effect of fructose intake in UK black West African and Caribbean people, to understand if fructose intake is indeed a reason for these ethnic differences.
Detailed description
The overall nature of this study is to conduct an investigation into the metabolic effects of acute high fructose versus high glucose feeding in people of Black African (BA) compared to age and BMI-matched control subjects of White-European (WE) origin . The research question of our study is: do people of BA metabolise fructose differently than people of WE when challenged with a high sugar diet? Therefore, our specific aims are to determine the following in both people of BA and WE consuming both high fructose and high glucose meals: 1) the postprandial pattern of blood insulin, glucose, triglyceride and cholesterol concentrations; 2) ambulatory blood pressure measures during the postprandial period and 4) postprandial and 0-24-hour fasted serum and red blood cell membrane cholesterol and non-cholesterol sterol concentrations.
Potential participants will attend the scheduled screening session where the requirements of participation will be described and the participants will be given an opportunity to ask any questions they may have. Those still willing to participate will sign the informed consent form before the screening assessment is performed. Screening will require a fasted blood sample to be taken as well as a brief questionnaire to ascertain ethnicity (self-declared), medications and health status. An assessment of weight, height and waist circumference will also be taken to confirm they meet the inclusion criteria. It is expected that the results of the screening blood sample will be available within 1-2 weeks. Those participants meeting the inclusion criteria will be contacted and scheduled for the first study visit. Those not meeting the criteria will be notified by their preferred means of contact, a copy of their results will be provided.
Prior to attending participants treatment order will be randomized. Participants will report to the Metabolic Research Unit (MRU) at 08.00 following an overnight fast. A catheter will be inserted into an antecubital vein for collection of blood samples and a baseline blood sample collected at this time. Participant will be asked to undertake minimal physical activity during the remainder of the study period. A breakfast meal will be given at 0min, the lunch meal at 240min and meals will be consumed within 15 minutes. Participants will be fitted with a portable continuous blood pressure and heart rate monitor (arteriograph) and instructed on what to expect as it functions. Further blood samples will be taken at -30, -15, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420min and at 24hrs (1440min, fasted). The energy content of the meals will be the estimated energy requirements of the participant (to the nearest 100kcals), with 20% of total daily energy coming from glucose or fructose. The glucose or fructose will be given dissolved water with added colour and orange/fruit flavours and provided at breakfast, lunch and supper. The remaining daily caloric requirement for each participant will be given a standardized evening meal to take away and consume at home.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Sugar - Fructose | Experimental | Dietary Supplement: Dietary sugarEach participant consumed 20% daily caloric requirement as fructose. |
| Dietary Sugar - Glucose | Active comparator | Dietary Supplement: Dietary sugarEach participant consumed 20% daily caloric requirement as glucose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Self-reported healthy, confirmed by blood tests (i.e. liver enzymes, full blood count, lipids, glucose); ethnicity White European participants had at least 3 grandparents originating from countries of Europe and Black African participants had at least 3 grandparents originating primarily from countries of West Africa (Economic Community of West African States (ECOWAS) and central African countries (e.g. Cameroon, Uganda, etc).
Key exclusion criteria (1 listed)
- fasting glucose in the diabetic range (fasting glucose >7 mmol/l); hypertension (medically diagnosed or >140/90 mm Hg at screening); hyperlipidaemia deemed to require immediate medical intervention (defined as: total cholesterol >6.0 mmol/l; LDL-cholesterol >4.5 mmol/l; fasting TG >3 mmol/l).
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 |
|---|---|---|
| Dietary sugarThis study examined the effect of high intakes of fructose compared to high intakes of glucose in a randomized crossover design. The treatment was in replacement of 20% of the daily caloric requirements for either fructose or glucose for each individual. | Dietary supplement | Dietary Sugar - Fructose, Dietary Sugar - Glucose |
Primary outcome
Postprandial triglyceride concentrations
Time frame: 0-420 minutes
At time 0 minutes participants were provided with a study breakfast which they were required to consume within a 15 minute period and subsequent blood samples were drawn at 15, 30, 45, 60, 90, 120, 180, 240, 300, 360 and 420 minutes. The lunch meal was consumed immediately following the 240 minute blood sample and final fructose/glucose drink was consumed immediately following the 420 minute blood sample. A final blood sample was drawn at 24 hours under fasting conditions.
5 secondary outcomes
Postprandial glucose concentrations.
Time frame: 0-420 minutes
Serum and red blood cell cholesterol and non-cholesterol sterol concentrations
Time frame: 0 and 24-hour post treatment
Postprandial insulin concentrations
Time frame: 0-420 minutes
Postprandial c-peptide concentrations
Time frame: 0-420 minutes
Postprandial non-esterified fatty acid concentrations
Time frame: 0-420 minutes
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 12 May 2016.
- Derived from this study: PubMed 27590876Goff LM, Whyte MB, Samuel M, Harding SV. Significantly greater triglyceridemia in Black African compared to White European men following high added fructose and glucose feeding: a randomized crossover trial. Lipids Health Dis. 2016 Sep 2;15(1):145. doi: 10.1186/s12944-016-0315-3.
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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.
Scott V Harding, PhD principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
A study testing Dietary sugar in people with Healthy, run by King's College London.
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 1 inclusion and 1 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Postprandial triglyceride concentrations (time frame: 0-420 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533817, which also lists 1 linked publication.
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 12 May 2016.