NCT04203758CompletedNot Applicable
High Fiber Rye Foods for Body Weight and Body Fat Reduction - The RyeWeight2 Study, a Randomized Controlled Trial.
Chalmers University of Technology1 site in 1 country255 target enrollmentStarted: January 20, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 255
- Locations
- 1
- Primary Endpoint
- Investigate if there is a difference in body fat mass at week 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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.
Outcomes
Primary Outcomes
Investigate if there is a difference in body fat mass at week 12
Time Frame: 12 weeks
Measured by dual energy x-ray absorptiometry
Investigate if there is a difference in body weight at week 12
Time Frame: 12 weeks
Measured on a scale
Secondary Outcomes
- Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention(6 weeks and 12 weeks)
- 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 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)
- 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.)
- Investigate if differences in primary endpoints (body weight) are apparent at week 6(6 weeks)
- Investigate if differences in primary endpoints (fat mass) are apparent at week 6(6 weeks)
- 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 abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention(6 weeks and 12 weeks)
- 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)
Investigators
Rikard Landberg
Professor
Chalmers University of Technology
Study Sites (1)
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