Obesity, Overweight
Conditions
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.
Interventions
OTHERCereal products based on rye
Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.
OTHERCereal products based on wheat
Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.
Sponsors
Chalmers University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Investigate if differences in primary endpoints (fat mass) are apparent at week 6 | 6 weeks | Measured by dual energy x-ray absorptiometry |
| 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 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 triglycerides differ between groups | 6 weeks and 12 weeks | — |
| Investigate if fasting plasma low-density lipoprotein cholesterol 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 fasting plasma total cholesterol differ between groups | 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 fasting serum insulin differ between groups | 6 weeks and 12 weeks | — |
| Investigate if C-reactive protein 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 hip circumference differ between intervention groups | 6 weeks and 12 weeks | — |
| Investigate if waist circumference differ between intervention | 6 weeks and 12 weeks | — |
| Investigate if sagittal height differ between intervention groups | 6 weeks and 12 weeks | — |
| Investigate if fasting plasma glucose differ between groups | 6 weeks and 12 weeks | — |
| Investigate if differences in primary endpoints (body weight) are apparent at week 6 | 6 weeks | Measured on a scale |
Countries
Sweden
Outcome results
None listed