ObesityHarboeNCT01615081
The Acute Effect of Malt Extract Versus Sucrose on the Response of Glucose and Insulin, Subjective Appetite Sensations and ad Libitum Energy Intake
A study testing The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake in people with Obesity and Diabetes, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with other composition and amount of carbohydrates could be of interest in order to decrease the glucose and insulin responses after intake of a sweetened beverage/food. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- What is being tested?
- The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Oct 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy,
- BMI: 18.5-24.9 kg/m2,
- Weight stable (within +/- 3 kg) two months prior to study inclusion,
- Non-smoking,
- Nonathletic (< 10 h hard physical activity),
Who cannot join
- BMI > 25 kg/m2,
- Change in smoking status,
- Daily or frequent use of medication,
- Suffering from metabolic diseases,
- Suffering from psychiatric diseases,
- Suffering from any other clinical condition, which would make the subject unfit to participate in the study,
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- Hemoglobin < 7.5 mmol/l.
- alcohol and drug abuse
- blood donation, 3mo prior to the present study and during study participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Science, University of Copenhagen
Frederiksberg, 1958
About this study
Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with other composition and amount of carbohydrates could be of interest in order to decrease the glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a sweet flavor but contains a different composition and amount of carbohydrates together with a small amount of protein compared to sucrose. Malt extract may therefore be a better alternative than sucrose as a sweetener due to a lower increase and more sustained blood glucose level. This could be of interest in relation to diabetes and appetite regulation but this is yet to be investigated.
Thus the objective is to investigate the effect of malt extract vs. sucrose on:
Read more
- 3-hour change in the concentration of glucose and insulin
- 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)
- Ad libitum energy intake
Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch
- Being tested
- The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake
- Keywords
- Malt extract, carbohydrate, glucose response, insulin response, Appetite, Appetite regulating hormones
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intakeOther
2-arm crossover study for investigation of the effect of malt extract vs. sucrose on glucose, insulin, subjective appetite sensations and ad libitum energy intake.
| Study group | Role | What they receive |
|---|---|---|
| Sucrose solution | Active comparator | 75 g sucrose (75 g carbohydrate) desolved in 750 ml water Receives: Other: The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake |
| Malt extract solution | Experimental | 183 g malt extract (corresponding to 75 g carbohydrate and 103 ml water) desolved in 647 ml water Receives: Other: The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute 3-h changes from baseline in the postprandial concentration of glucose
Blood samples are taken prior to the test drink (baseline). After initiation of the test drink blood samples are collected at time 15, 30, 45, 60, 90, 120, 150, 180 minutes. Blood samples are analyzed for glucose.
Measured: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day glucose is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Secondary outcomes (7)
Acute 3-h changes from baseline in the postprandial concentration of insulin
Blood samples are taken prior to the test drink(baseline). After initiation of the test drink blood samples are collected at time 15, 30, 45, 60, 90, 120, 150, 180 minutes. Blood samples are analyzed for insulin.
Measured: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day insulin is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales
Assessment of subjective appetite sensations (visual analogue scales (VAS)) at time 0 (baseline - prior to the test meal) and at time 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake.
Measured subjective appetite sensations of hunger, satiety, prospective consumption, fullness, composite appetite score and sensory desires to something sweet, salty, rich in fat, or meat/fish.
Measured: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day appetite sensations are measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Rating of the organoleptic quality of the test drinks
After completion of the test drink the subjects will rate the organoleptic quality of the drink by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability.
Measured: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the test drink (approximately) time 5 minutes post intake) subjects will rate the test drink
Rating of the organoleptic quality of the ad libitum meal
After completion of the adlibitum meal the subjects will rate the organoleptic quality of the meal by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability.
Measured: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal
Subjective appetite sensations (visual analogue scales) after ad libitum meal
After completion of the ad libitum meal the subjects will rate the subjective appetite sensations by visual analogue scales (VAS) in regard to sensation of hunger, satiety, prospective consumption, fullness, composite appetite score and sensory desires to eat something sweet, salty, rich in fat, or meat/fish.
Measured: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. After completion of the ad libitum meal subjects will rate their subjective sensation of appetite (approx 3.5-h post intake of test drink)
change in body weight and composition (fat mass and fat free mass)
body weight will be measured to the nearest 0.05 kg on a decimal scale. Body composition will be assessed by electric bioimpedance using an Animeter.
Measured: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day body weight and composition is carried out prior to the test.
ad libitum energy intake (EI)
180 min after each test drink an ad libitum meal was served, and the total energy intake was recorded
Measured: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. EI was measured 180 min after intake of the test drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Anne B Raben, Professor, Principal investigator, Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615081
- Sponsor's protocol ID
- B287
- Acronym
- Harboe
- Status last verified
- Oct 2012
- First submitted
- 6 Jun 2012
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Malt Extract Versus Sucrose on the Response of Glucose and Insulin, Subjective Appetite Sensations and ad Libitum Energy Intake
- ClinicalTrials.gov ID
- NCT01615081
- Acronym / sponsor ID
- Harboe / B287
- Keywords
- Malt extract, carbohydrate, glucose response, insulin response, Appetite, Appetite regulating hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 8 Jun 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.
Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with other composition and amount of carbohydrates could be of interest in order to decrease the glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a sweet flavor but contains a different composition and amount of carbohydrates together with a small amount of protein compared to sucrose. Malt extract may therefore be a better alternative than sucrose as a sweetener due to a lower increase and more sustained blood glucose level. This could be of interest in relation to diabetes and appetite regulation but this is yet to be investigated.
Thus the objective is to investigate the effect of malt extract vs. sucrose on:
- 3-hour change in the concentration of glucose and insulin
- 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)
- Ad libitum energy intake
Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose solution | Active comparator | Other: The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake75 g sucrose (75 g carbohydrate) desolved in 750 ml water |
| Malt extract solution | Experimental | Other: The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake183 g malt extract (corresponding to 75 g carbohydrate and 103 ml water) desolved in 647 ml water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy,
- BMI: 18.5-24.9 kg/m2,
- Weight stable (within +/- 3 kg) two months prior to study inclusion,
- Non-smoking,
- Nonathletic (< 10 h hard physical activity),
Key exclusion criteria (9 listed)
- BMI > 25 kg/m2,
- Change in smoking status,
- Daily or frequent use of medication,
- Suffering from metabolic diseases,
- Suffering from psychiatric diseases,
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 |
|---|---|---|
| The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake2-arm crossover study for investigation of the effect of malt extract vs. sucrose on glucose, insulin, subjective appetite sensations and ad libitum energy intake. | Other | Malt extract solution, Sucrose solution |
Primary outcome
Acute 3-h changes from baseline in the postprandial concentration of glucose
Time frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day glucose is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Blood samples are taken prior to the test drink (baseline). After initiation of the test drink blood samples are collected at time 15, 30, 45, 60, 90, 120, 150, 180 minutes. Blood samples are analyzed for glucose.
7 secondary outcomes
Acute 3-h changes from baseline in the postprandial concentration of insulin
Time frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day insulin is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales
Time frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day appetite sensations are measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake
Rating of the organoleptic quality of the test drinks
Time frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the test drink (approximately) time 5 minutes post intake) subjects will rate the test drink
Rating of the organoleptic quality of the ad libitum meal
Time frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal
Subjective appetite sensations (visual analogue scales) after ad libitum meal
Time frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. After completion of the ad libitum meal subjects will rate their subjective sensation of appetite (approx 3.5-h post intake of test drink)
change in body weight and composition (fat mass and fat free mass)
Time frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. On each test day body weight and composition is carried out prior to the test.
ad libitum energy intake (EI)
Time frame: Measured on 2 seperate test days in a crossover design. Each test seperated by >2 weeks. EI was measured 180 min after intake of the test drink
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 5 Oct 2012.
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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.
Anne B Raben, Professor principal investigator
Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake in people with Obesity and Diabetes, run by University of Copenhagen at 1 site in Denmark.
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 5 inclusion and 9 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 5 Oct 2012. 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 Denmark. 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. 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?
Acute 3-h changes from baseline in the postprandial concentration of glucose (time frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >2 weeks. On each test day glucose is measured prior to the test drink (time 0) and 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake). 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 5 Oct 2012.