Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:01 AM
Study NCT ID:
NCT07372235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SSRD and Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Mean weight at 3 Months.', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Change from Baseline in the Mean waist circumference at 3 Months', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Change from Baseline in the body mass composition at 3 Months', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The change from baseline in the endocrine profile in blood at 3 months', 'timeFrame': '1 year', 'description': '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'}, {'measure': 'The change from baseline in the metabolic profile in blood at 3 months', 'timeFrame': '1 year', 'description': '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'}, {'measure': 'The change from baseline in the epigenetic profile measured in blood at 3 months', 'timeFrame': '1 year', 'description': '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'}, {'measure': 'The change from baseline in the nutrient profile in blood at 3 months', 'timeFrame': '1 year', 'description': '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'}, {'measure': 'The change from baseline in the inflammatory profile in blood at 3 months', 'timeFrame': '1 year', 'description': '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 analyse inflammatory parameters. 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 inflammatory profile from baseline will be calculated, where the changes at 3 months will be the main outcome'}, {'measure': 'The change from baseline in the gut microbiota profile measured in feces at 3 months', 'timeFrame': '1 year', 'description': '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 feces samples are collected. 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 gut microbiota profile from baseline will be calculated, where the changes at 3 month will be the main outcome'}, {'measure': 'The change from baseline in the quality of life at 3 months', 'timeFrame': '1 year', 'description': '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 study questionnaires regarding quality of life are completed, and blood and feces samples are collected. 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 quality of life (assessed by HAD, PHQ12-SS, and RAND-36) from baseline will be calculated, where the changes at 3 month will be the main outcome'}, {'measure': 'The change from baseline in bowel symptoms registered by VAS at 3 months', 'timeFrame': '1 year', 'description': '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 study questionnaires regarding bowel symptmos are completed. Bowel symptoms are assessed on visual analog scales (VAS) from 0 mm (no symptoms) to 100 (max symptoms). 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 bowel symptoms from baseline will be calculated, where the changes at 3 month will be the main outcome'}, {'measure': 'The change from baseline in the nutrient intake registered in digital diary food books at 3 months', 'timeFrame': '1 year', 'description': '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. Dietary registrations are performed digitally during 3 days at all time points for physical visits. 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 intake according to the dietary registrations from baseline will be calculated, where the changes at 3 month will be the main outcome'}, {'measure': 'The change from baseline in the inflammatory profile in feces at 3 months', 'timeFrame': '1 year', 'description': '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 feces samples are collected to analyse inflammatory parameters. 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 inflammatory profile from baseline will be calculated, where the changes at 3 months will be the main outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overweight', 'SSRD', 'metabolomics', 'feedback on dietary efficiency'], 'conditions': ['Overweight (BMI > 25)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ålder 18-70 år och språkkunskaper i svenska så att de kan tillgodogöra sig kostinformationen och ifylla formulären.\n* BMI ≥25 kg/m2\n\nExclusion Criteria:\n\n* Allvarlig födoämnesallergi\n* Allvarlig hjärt, lung, kardiovaskulär, magtarm, malign eller psykisk sjukdom\n* Pågående ätstörning\n* Graviditet\n* 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\n* Alkohol och/eller drogberoende\n* Stora ändringar i kroppsvikt de senaste 3 månaderna (≥3 kg)\n* Står på viktreducerande läkemedel eller läkemedel som typ GLP-1 analoger'}, 'identificationModule': {'nctId': 'NCT07372235', 'acronym': 'SSRD', 'briefTitle': 'SSRD and Overweight', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Comparison at Overweight Between Those Who Receive Feedback Concerning Their Metabolic Profile or Not During an Intervention With Modified Starch- and Sucrosereduced Diet (SSRD)', 'orgStudyIdInfo': {'id': '2025-07349-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary intervention without feedback', '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', 'interventionNames': ['Other: Dietary intervention with SSRD without any feedback on metabolic profile']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary intervention with feedback', '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', 'interventionNames': ['Other: Dietary intervention with SSRD in combination with feedback information about the metabolic profile']}], 'interventions': [{'name': 'Dietary intervention with SSRD in combination with feedback information about the metabolic profile', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Dietary intervention with feedback']}, {'name': 'Dietary intervention with SSRD without any feedback on metabolic profile', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Dietary intervention without feedback']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bodil Ohlsson, Professor', 'role': 'CONTACT', 'email': 'bodil.ohlsson@med.lu.se', 'phone': '+46 040 33 23 23'}, {'name': 'Olle Melander, Professor', 'role': 'CONTACT', 'email': 'olle.melander@med.lu.se'}], 'overallOfficials': [{'name': 'Cecilia Kennbäck, Registered Nurse', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Internal Medicine, Skåne University Hospital, 20502 Malmö'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to ethical rules, it is not allowed to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Skåne FoUU', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bodil Ohlsson', 'investigatorAffiliation': 'Region Skane'}}}}