High Fiber Rye Foods for Body Weight and Body Fat Reduction

NCT ID: NCT04203758

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2021-06-08

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.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Wholegrain rye products with a high content of dietary fiber

Cereal products based on wholegrain rye

Group Type: EXPERIMENTAL

Cereal products based on rye

Intervention Type: OTHER

Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.

Refined wheat products with a low content of dietary fiber

Cereal products based on refined wheat

Group Type: ACTIVE_COMPARATOR

Cereal products based on wheat

Intervention Type: OTHER

Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.

Interventions

Cereal products based on rye

Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.

Intervention Type: OTHER

Cereal products based on wheat

Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chalmers University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Rikard Landberg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rikard Landberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Chalmers University of Technology

Locations

Chalmers University of Technology

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

RW2

Identifier Type: -

Identifier Source: org_study_id