Clinical trial

SSRD and Overweight

Opening soon · Not applicable · 0 countries · Registry ID NCT07372235

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight (BMI > 25)

Full registry criteria

Inclusion Criteria: * Ålder 18-70 år och språkkunskaper i svenska så att de kan tillgodogöra sig kostinformationen och ifylla formulären. * BMI ≥25 kg/m2 Exclusion Criteria: * Allvarlig födoämnesallergi * Allvarlig hjärt, lung, kardiovaskulär, magtarm, malign eller psykisk sjukdom * Pågående ätstörning * Graviditet * Står redan på en diet såsom vegan diet, regelbunden fasta \>15 timmar per dag, eller låg kolhydrat hög fett (LCHF) diet de senaste 3 månaderna * Alkohol och/eller drogberoende * Stora ändringar i kroppsvikt de senaste 3 månaderna (≥3 kg) * Står på viktreducerande läkemedel eller läkemedel som typ GLP-1 analoger

Treatments and study arms

Dietary intervention with SSRD in combination with feedback information about the metabolic profile

Other

All 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

All particpants will receive informaiton about the SSRD diet. However, the participants will not be informed about the metabolic profile at the 6-week control

Primary outcomes

Change from Baseline in the Mean weight at 3 Months.1 year

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.

Change from Baseline in the Mean waist circumference at 3 Months1 year

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.

Change from Baseline in the body mass composition at 3 Months1 year

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.

Study locations

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No public site location was included in this record. Check the original registry for updates.