High Fiber Rye Foods for Body Weight and Body Fat Reduction

High Fiber Rye Foods for Body Weight and Body Fat Reduction - The RyeWeight2 Study, a Randomized Controlled Trial.

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.

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.