High Fiber Rye Foods for Weight and Body Fat Reduction

NCT ID: NCT03097237

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-12-31

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 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.

Conditions

Overweight; Obesity

Study Design

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

Study Groups

Wholegrain rye

Wholegrain rye products with a high content of dietary fiber

Group Type: EXPERIMENTAL

Wholegrain rye

Intervention Type: OTHER

Cereal products based on wholegrain rye

Refined wheat

Refined wheat products with a low content of dietary fiber

Group Type: ACTIVE_COMPARATOR

Refined wheat

Intervention Type: OTHER

Cereal products based on refined wheat

Interventions

Wholegrain rye

Cereal products based on wholegrain rye

Intervention Type: OTHER

Refined wheat

Cereal products based on refined wheat

Intervention Type: OTHER

Other Intervention Names

Control

Eligibility Criteria

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.

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

Sponsors

Swedish University of Agricultural Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Rikard Landberg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rikard Landberg, Dr

Role: PRINCIPAL_INVESTIGATOR

Chalmers University of Technology

Locations

Chalmers University of Technology

Gothenburg, , Sweden

Countries

Sweden

References

Iversen KN, Carlsson F, Andersson A, Michaelsson K, Langton M, Riserus U, Hellstrom PM, Landberg R. A hypocaloric diet rich in high fiber rye foods causes greater reduction in body weight and body fat than a diet rich in refined wheat: A parallel randomized controlled trial in adults with overweight and obesity (the RyeWeight study). Clin Nutr ESPEN. 2021 Oct;45:155-169. doi: 10.1016/j.clnesp.2021.07.007. Epub 2021 Jul 24.

Reference Type: DERIVED

PMID: 34620312 (View on PubMed)

Other Identifiers

SLU254

Identifier Type: -

Identifier Source: org_study_id