High Fiber Rye Foods for Body Weight and Body Fat Reduction (RyeWeight2)

Chalmers University of Technology

Status

Completed

Conditions

Overweight

Obesity

Treatments

Other: Cereal products based on rye

Other: Cereal products based on wheat

Study type

Interventional

Funder types

Other

Identifiers

NCT04203758

RW2

Details and patient eligibility

About

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.

Enrollment

255 patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.