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

Swedish University of Agricultural Sciences

Status

Completed

Conditions

Overweight

Obesity

Treatments

Other: Wholegrain rye

Other: Refined wheat

Study type

Interventional

Funder types

Other

Identifiers

NCT03097237

SLU254

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 hypocaloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention. Furthermore the study will investigate the effect on appetite as a potential underlying mechanism for differences in weight loss and body fat reduction.

Enrollment

242 patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

BMI 27-35 kg/m2
Hb≥120g/l
Serum thyroid stimulating hormone (TSH) ≤4.00 mIU/L
Plasma low density lipoprotein cholesterol <5.3 mmol/L
Plasma triglycerides ≤1.8 mmol/L
Signed informed consent
Freezer capacity for 2 weeks bread provision

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 complete satisfactorily the 3-day weighted food record at screening visit 2.
Unable to lose 0.5 kg or more 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 mm Hg at visit 1
Systolic blood pressure 160 mm 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
Have 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
Thyroid 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 (will be included in the list of allowed/disallowed medications)
Pregnant or lactating or wish to become pregnant during the period of the study.
Food allergies or intolerances
Vegetarian (due to the standardized meals for appetite measurements)
Unable to understand written and spoken Swedish
Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.