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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: Cereal products based on rye; Other: Cereal products based on wheat

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Chalmers University of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wholegrain rye products with a high content of dietary fiber; Cereal products based on wholegrain rye	Other: Cereal products based on rye; Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.
Active Comparator: Refined wheat products with a low content of dietary fiber; Cereal products based on refined wheat	Other: Cereal products based on wheat; Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate if there is a difference in body weight at week 12	Measured on a scale	12 weeks
Investigate if there is a difference in body fat mass at week 12	Measured by dual energy x-ray absorptiometry	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate if there are differences in subjective appetite ratings	Measured by visual analogue scale (assessing hunger fullness and desire to eat), throughout a whole day (8:00-21:00), at baseline, week 6 and week 12.	0 weeks, 6 weeks and 12 weeks.
Investigate if differences in primary endpoints (body weight) are apparent at week 6	Measured on a scale	6 weeks
Investigate if differences in primary endpoints (fat mass) are apparent at week 6	Measured by dual energy x-ray absorptiometry	6 weeks
Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention	Measured by dual energy x-ray absorptiometry	6 weeks and 12 weeks
Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention	Measured by dual energy x-ray absorptiometry	6 weeks and 12 weeks
Investigate if fasting plasma triglycerides differ between groups		6 weeks and 12 weeks
Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups		6 weeks and 12 weeks
Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups		6 weeks and 12 weeks
Investigate if fasting plasma total cholesterol differ between groups		6 weeks and 12 weeks
Investigate if fasting plasma glucose differ between groups		6 weeks and 12 weeks
Investigate if fasting serum insulin differ between groups		6 weeks and 12 weeks
Investigate if C-reactive protein differ between groups		6 weeks and 12 weeks
Investigate if gut microbiota composition is affected by the intervention	Gut microbiota composition will be analyzed using 16S ribosomal ribonucleic acid (rRNA) sequencing	6 weeks and 12 weeks
Investigate if hip circumference differ between intervention groups		6 weeks and 12 weeks
Investigate if waist circumference differ between intervention		6 weeks and 12 weeks
Investigate if sagittal height differ between intervention groups		6 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Chalmers University of Technology
• Investigators: Principal Investigator: Rikard Landberg, PhD, Chalmers University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): June 8, 2021

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: RW2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No