High Fiber Rye Foods for Body Weight and Body Fat Reduction
Not Applicable
Completed
- Conditions
- OverweightObesity
- Interventions
- Other: Cereal products based on wheatOther: Cereal products based on rye
- Registration Number
- NCT04203758
- Lead Sponsor
- Chalmers University of Technology
- Brief Summary
The overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypo-caloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
Inclusion Criteria
- Men and women
- Age 30-70 y
- BMI 27-35 kg/m2
- Hemoglobin ≥117g/l for women and for men ≥134g/l
- Thyroid stimulating hormone (TSH) ≤4.30 mIU/L
- Low density lipoprotein (LDL) cholesterol ≤5.30 mmol/L
- Triglycerides ≤2.60 mmol/L
- Signed informed consent
Exclusion Criteria
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
- Unable to satisfactorily complete the 3-day weighted food record between screening visits.
- Unable to lose ≥0.5 kg during the run-in period for men and women not having menstruation during the run-in period
- Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period.
- Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
- Using e-cigarettes (regardless of nicotine content)
- Following any weight reduction program or having followed one during the last 6 months prior to visit 1.
- Diastolic blood pressure 105 mmHg or more at visit 1
- Systolic blood pressure 160 mmHg or more at visit 1
- History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
- More than 10 hours physical activity per week
- History of heart failure or heart attack within 1 year prior to screening
- Having type I diabetes
- Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol)
- Previous gastrointestinal surgery, with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.
- Thyroid disorder
- History of eating disorder
- History of drug or alcohol abuse
- Stroke or transient ischemic attack (TIA) within 1 year prior to screening
- Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.
- Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.
- Food allergies or intolerances preventing consumption of any products included in the study
- Strict vegetarian (participants must be able to consume the standardized meals used for appetite assessment)
- Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
- Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or PI.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Refined wheat products with a low content of dietary fiber Cereal products based on wheat Cereal products based on refined wheat Wholegrain rye products with a high content of dietary fiber Cereal products based on rye Cereal products based on wholegrain rye
- Primary Outcome Measures
Name Time Method Investigate if there is a difference in body weight at week 12 12 weeks Measured on a scale
Investigate if there is a difference in body fat mass at week 12 12 weeks Measured by dual energy x-ray absorptiometry
- Secondary Outcome Measures
Name Time Method Investigate if fasting plasma total cholesterol differ between groups 6 weeks and 12 weeks Investigate if fasting plasma glucose differ between groups 6 weeks and 12 weeks Investigate if gut microbiota composition is affected by the intervention 6 weeks and 12 weeks Gut microbiota composition will be analyzed using 16S ribosomal ribonucleic acid (rRNA) sequencing
Investigate if waist circumference differ between intervention 6 weeks and 12 weeks Investigate if there are differences in subjective appetite ratings 0 weeks, 6 weeks and 12 weeks. Measured by visual analogue scale (assessing hunger fullness and desire to eat), throughout a whole day (8:00-21:00), at baseline, week 6 and week 12.
Investigate if differences in primary endpoints (body weight) are apparent at week 6 6 weeks Measured on a scale
Investigate if differences in primary endpoints (fat mass) are apparent at week 6 6 weeks Measured by dual energy x-ray absorptiometry
Investigate if fasting plasma triglycerides differ between groups 6 weeks and 12 weeks Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups 6 weeks and 12 weeks Investigate if C-reactive protein differ between groups 6 weeks and 12 weeks Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention 6 weeks and 12 weeks Measured by dual energy x-ray absorptiometry
Investigate if fasting serum insulin differ between groups 6 weeks and 12 weeks Investigate if hip circumference differ between intervention groups 6 weeks and 12 weeks Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention 6 weeks and 12 weeks Measured by dual energy x-ray absorptiometry
Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups 6 weeks and 12 weeks Investigate if sagittal height differ between intervention groups 6 weeks and 12 weeks
Trial Locations
- Locations (1)
Chalmers University of Technology
🇸🇪Gothenburg, Sweden