Clinical trial NCT01615081: The Acute Effect of Malt Extract Versus Sucrose on the Response of Glucose and Insulin, Subjective Appetite Sensations and ad Libitum Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Keywords: Malt extract
carbohydrate
glucose response
insulin response
Appetite
Appetite regulating hormones
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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. 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:

1. 3-hour change in the concentration of glucose and insulin
2. 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)
3. 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


Eligibility criteria: Inclusion Criteria:

* 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),

Exclusion Criteria:

* 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,
* Hemoglobin \< 7.5 mmol/l.
* alcohol and drug abuse
* blood donation, 3mo prior to the present study and during study participation

Primary outcomes:
measure: Acute 3-h changes from baseline in the postprandial concentration of glucose
timeFrame: 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:
measure: Acute 3-h changes from baseline in the postprandial concentration of insulin
timeFrame: 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
measure: Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales
timeFrame: 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
measure: Rating of the organoleptic quality of the test drinks
timeFrame: 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
measure: Rating of the organoleptic quality of the ad libitum meal
timeFrame: 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
measure: Subjective appetite sensations (visual analogue scales) after ad libitum meal
timeFrame: 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)
measure: change in body weight and composition (fat mass and fat free mass)
timeFrame: 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.
measure: ad libitum energy intake (EI)
timeFrame: 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
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, Faculty of Science, University of Copenhagen
Study officials:
affiliation: Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
name: Anne B Raben, Professor
role: PRINCIPAL_INVESTIGATOR
References: