Comparison at Overweight Between Those Who Receive Feedback Concerning Their Metabolic Profile or Not During an Intervention With Modified Starch- and Sucrosereduced Diet (SSRD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Region Skane
- 入组人数
- 300
- 主要终点
- Change from Baseline in the Mean weight at 3 Months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ålder 18-70 år och språkkunskaper i svenska så att de kan tillgodogöra sig kostinformationen och ifylla formulären.
- •BMI ≥25 kg/m2
排除标准
- •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
研究组 & 干预措施
Dietary intervention without feedback
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
干预措施: Dietary intervention with SSRD without any feedback on metabolic profile (Other)
Dietary intervention with feedback
All participants in this arm will be recommended SSRD, and they receive information about changes in their metabolic profiles after the 6-week control
干预措施: Dietary intervention with SSRD in combination with feedback information about the metabolic profile (Other)
结局指标
主要结局
Change from Baseline in the Mean weight at 3 Months.
时间窗: 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 Months
时间窗: 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 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 Months
时间窗: 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, 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.
次要结局
- 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)
- The change from baseline in the gut microbiota profile measured in feces at 3 months(1 year)
- The change from baseline in the quality of life at 3 months(1 year)
- The change from baseline in bowel symptoms registered by VAS at 3 months(1 year)
- The change from baseline in the nutrient intake registered in digital diary food books at 3 months(1 year)
- The change from baseline in the inflammatory profile in feces at 3 months(1 year)