SSRD and Overweight

Официальное название

Comparison at Overweight Between Those Who Receive Feedback Concerning Their Metabolic Profile or Not During an Intervention With Modified Starch- and Sucrosereduced Diet (SSRD)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Dietary intervention with SSRD in combination with feedback information about the metabolic profile
  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.
• Другое Dietary intervention with SSRD without any feedback on metabolic profile
  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

Первичные конечные точки

• Change from Baseline in the Mean weight at 3 Months. [Срок оценки: 1 year]
• Change from Baseline in the Mean waist circumference at 3 Months [Срок оценки: 1 year]
• Change from Baseline in the body mass composition at 3 Months [Срок оценки: 1 year]

Вторичные конечные точки (10)

• The change from baseline in the endocrine profile in blood at 3 months [Срок оценки: 1 year]
• The change from baseline in the metabolic profile in blood at 3 months [Срок оценки: 1 year]
• The change from baseline in the epigenetic profile measured in blood at 3 months [Срок оценки: 1 year]
• The change from baseline in the nutrient profile in blood at 3 months [Срок оценки: 1 year]
• The change from baseline in the inflammatory profile in blood at 3 months [Срок оценки: 1 year]
• The change from baseline in the gut microbiota profile measured in feces at 3 months [Срок оценки: 1 year]
• The change from baseline in the quality of life at 3 months [Срок оценки: 1 year]
• The change from baseline in bowel symptoms registered by VAS at 3 months [Срок оценки: 1 year]
• The change from baseline in the nutrient intake registered in digital diary food books at 3 months [Срок оценки: 1 year]
• The change from baseline in the inflammatory profile in feces at 3 months [Срок оценки: 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07372235 · 2025-07349-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗