SSRD and Overweight

Region Skane

Status: Begins enrollment this month

Conditions: Overweight (BMI > 25)

Treatments: Other: Dietary intervention with SSRD in combination with feedback information about the metabolic profile; Other: Dietary intervention with SSRD without any feedback on metabolic profile

Study type: Interventional

Funder types: Other

Identifiers

NCT07372235

2025-07349-01

Details and patient eligibility

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.

Full description

Patients with overweight or obesity will be recrutied to this open-label, randomized clinical trial. All participants will be informed about the starch- and sucrosereduced diet (SSRD). The diet will be continued for 3 months, with a physical visit with completion of study questionnaires, blood and feces sampling and measurements of anthropometry at baseline, after 6 weeks and 3 months. Thereafter, participants are free to eat whatever they want, but will be examined again after 1 year. Participants will be randomized to whether participants should be informed or not about the metabolic profile measured at week 6. Participants who are randomized to get information about the metabolic profile, will be called when the blood samples have been analysed, and informed about the changes in metabolic and nutrient results between baseline and 6 weeks. The investigators will then evaluate whether participants who were randomized to get information about their blood samples after 6 weeks, will have better compliance to the diet, and thereby have better effect on weight reduction and metabolic profiles. At the blood sampling after 3 months, all participants will be informed about their metabolic profiles. It is also of interest to study the effect at follow-up after 1 year, to see whether participants who were informed at 6 weeks differ from participants who were not.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Dietary intervention without feedback

Active Comparator group

Description:

All participants in this arm will be recommended SSRD, but they do not receive any information about changes in their metabolic profiles after the 6-week control

Treatment:

Other: Dietary intervention with SSRD without any feedback on metabolic profile

Dietary intervention with feedback

Active Comparator group

Description:

All participants in this arm will be recommended SSRD, and they receive information about changes in their metabolic profiles after the 6-week control

Treatment:

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