SSRD and Overweight
ConditionOverweight (BMI > 25)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRegion Skane
About this trial
The investigators have previously found that a starch- and sucrosereduced diet (SSRD) has led decreased gastrointestinal symptoms in patients with irritabel bowel syndrome (IBS). At the same time, investigators found that the weight was reduced and the nutrient intake was improved with a more favorable metabolic profile. However, it is a challenge to change lifestyle, and most persons fail to keep on with an improved diet for a long time. Investigators therefore now want to conduct a clinical trial with SSRD in overweight/obesity for 3 months. Persons with a BMI \>25 kg/m2 will be included. To examine whether a feedback about improved metabolic profile enhances the compliance, participants will be randomized to be informed or not about the metabolic profile after the 6-week visit. Investigator´s hypothesis is that information about the improvement in the metabolic profile should increase the motivation and compliance in the patients, and thereby render better effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ålder 18-70 år och språkkunskaper i svenska så att de kan tillgodogöra sig kostinformationen och ifylla formulären.
BMI ≥25 kg/m2
Disqualifiers
Allvarlig födoämnesallergi
Allvarlig hjärt, lung, kardiovaskulär, magtarm, malign eller psykisk sjukdom
Pågående ätstörning
Graviditet
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary intervention with SSRD in combination with feedback information about the metabolic profile
Other interventionAll participants will recieve a dietary intervention. They will be informed at the 6-week control about the changes in metabolic profile since study start.
Dietary intervention with SSRD without any feedback on metabolic profile
Other interventionAll particpants will receive informaiton about the SSRD diet. However, the participants will not be informed about the metabolic profile at the 6-week control
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Dietary intervention without feedbackActive comparator 1 intervention
Group B: Dietary intervention with feedbackActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Mean weight at 3 Months.
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where weight (kg) is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in weight from baseline will be calculated. The main outcome is the weight change observed at 3 months.
Time frame
1 year2
Change from Baseline in the Mean waist circumference at 3 Months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where waist circumferense (cm) is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in waist circumference from baseline will be calculated. The main outcome is the change observed at 3 months.
Time frame
1 year3
Change from Baseline in the body mass composition at 3 Months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, body mass composition is measured. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The reduction in fat mass from baseline will be calculated. The main outcome is the change observed at 3 months.
Time frame
1 yearSecondary outcomes
1
The change from baseline in the endocrine profile in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where blood samples are collected to measure the endocrine profile. Half of the participants are randomized to receive feedback on the metabolic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in the endocrine profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Time frame
1 year2
The change from baseline in the metabolic profile in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where blood samples are collected to measure the metabolic profile. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in metabolic profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Time frame
1 year3
The change from baseline in the epigenetic profile measured in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where blood samples are collected to measure epigenetics. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in epigenetic profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Time frame
1 year4
The change from baseline in the nutrient profile in blood at 3 months
All participants are instructed to eat a starch- and sucrosereduced diet (SSRD) during 3 months. Physical meetings are scheduled at baseline, week 6, month 3 and after 1 year, where blood samples are collected to measure the nutrient profile. Half of the participants are randomized to receive feedback on the metabloic profile after 6 weeks, and the other half will not get any feedback on their blood samples until after 3 months. The hypothesis is that those who recieve feedback on their metabolic profile in the middle of the intervention will be more motivated to follow the diet and be more compliant, which should result in better effects. The changes in nutrient profile from baseline will be calculated, where the changes at 3 month will be the main outcome
Time frame
1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: