SSRD and Overweight

NCT07372235 | Not Yet Recruiting

• 1 other identifier: 2025-07349-01
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Overweight (BMI > 25)

Keywords

overweight; SSRD; metabolomics; feedback on dietary efficiency

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

Secondary Outcomes (10)

• The change from baseline in the endocrine profile in blood at 3 months

  1 year

• The change from baseline in the metabolic profile in blood at 3 months

  1 year

• The change from baseline in the epigenetic profile measured in blood at 3 months

  1 year

• The change from baseline in the nutrient profile in blood at 3 months

  1 year

• The change from baseline in the inflammatory profile in blood at 3 months

  1 year

Study Arms (2)

Dietary intervention without feedback

ACTIVE COMPARATOR

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

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

Dietary intervention with feedback

ACTIVE COMPARATOR

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

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

Interventions

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 feedback

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

Dietary intervention without feedback

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ålder 18-70 år och språkkunskaper i svenska så att de kan tillgodogöra sig kostinformationen och ifylla formulären.
• BMI ≥25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

MeSH Terms

Conditions

Overweight

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Cecilia Kennbäck, Registered Nurse

  Department of Internal Medicine, Skåne University Hospital, 20502 Malmö

  STUDY CHAIR

Central Study Contacts

Bodil Ohlsson, Professor

CONTACT

+46 040 33 23 23; bodil.ohlsson@med.lu.se

Olle Melander, Professor

CONTACT

olle.melander@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share