search
Back to results

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

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cereal products based on rye
Cereal products based on wheat
Sponsored by
Chalmers University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Chalmers University of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wholegrain rye products with a high content of dietary fiber

Refined wheat products with a low content of dietary fiber

Arm Description

Cereal products based on wholegrain rye

Cereal products based on refined wheat

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Investigate if differences in primary endpoints (body weight) are apparent at week 6
Measured on a scale
Investigate if differences in primary endpoints (fat mass) are apparent at week 6
Measured by dual energy x-ray absorptiometry
Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention
Measured by dual energy x-ray absorptiometry
Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention
Measured by dual energy x-ray absorptiometry
Investigate if fasting plasma triglycerides differ between groups
Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups
Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups
Investigate if fasting plasma total cholesterol differ between groups
Investigate if fasting plasma glucose differ between groups
Investigate if fasting serum insulin differ between groups
Investigate if C-reactive protein differ between groups
Investigate if gut microbiota composition is affected by the intervention
Gut microbiota composition will be analyzed using 16S ribosomal ribonucleic acid (rRNA) sequencing
Investigate if hip circumference differ between intervention groups
Investigate if waist circumference differ between intervention
Investigate if sagittal height differ between intervention groups

Full Information

First Posted
December 13, 2019
Last Updated
July 16, 2021
Sponsor
Chalmers University of Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT04203758
Brief Title
High Fiber Rye Foods for Body Weight and Body Fat Reduction
Acronym
RyeWeight2
Official Title
High Fiber Rye Foods for Body Weight and Body Fat Reduction - The RyeWeight2 Study, a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
June 8, 2021 (Actual)
Study Completion Date
June 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chalmers University of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wholegrain rye products with a high content of dietary fiber
Arm Type
Experimental
Arm Description
Cereal products based on wholegrain rye
Arm Title
Refined wheat products with a low content of dietary fiber
Arm Type
Active Comparator
Arm Description
Cereal products based on refined wheat
Intervention Type
Other
Intervention Name(s)
Cereal products based on rye
Intervention Description
Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.
Intervention Type
Other
Intervention Name(s)
Cereal products based on wheat
Intervention Description
Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.
Primary Outcome Measure Information:
Title
Investigate if there is a difference in body weight at week 12
Description
Measured on a scale
Time Frame
12 weeks
Title
Investigate if there is a difference in body fat mass at week 12
Description
Measured by dual energy x-ray absorptiometry
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Investigate if there are differences in subjective appetite ratings
Description
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.
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Investigate if differences in primary endpoints (body weight) are apparent at week 6
Description
Measured on a scale
Time Frame
6 weeks
Title
Investigate if differences in primary endpoints (fat mass) are apparent at week 6
Description
Measured by dual energy x-ray absorptiometry
Time Frame
6 weeks
Title
Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention
Description
Measured by dual energy x-ray absorptiometry
Time Frame
6 weeks and 12 weeks
Title
Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention
Description
Measured by dual energy x-ray absorptiometry
Time Frame
6 weeks and 12 weeks
Title
Investigate if fasting plasma triglycerides differ between groups
Time Frame
6 weeks and 12 weeks
Title
Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups
Time Frame
6 weeks and 12 weeks
Title
Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups
Time Frame
6 weeks and 12 weeks
Title
Investigate if fasting plasma total cholesterol differ between groups
Time Frame
6 weeks and 12 weeks
Title
Investigate if fasting plasma glucose differ between groups
Time Frame
6 weeks and 12 weeks
Title
Investigate if fasting serum insulin differ between groups
Time Frame
6 weeks and 12 weeks
Title
Investigate if C-reactive protein differ between groups
Time Frame
6 weeks and 12 weeks
Title
Investigate if gut microbiota composition is affected by the intervention
Description
Gut microbiota composition will be analyzed using 16S ribosomal ribonucleic acid (rRNA) sequencing
Time Frame
6 weeks and 12 weeks
Title
Investigate if hip circumference differ between intervention groups
Time Frame
6 weeks and 12 weeks
Title
Investigate if waist circumference differ between intervention
Time Frame
6 weeks and 12 weeks
Title
Investigate if sagittal height differ between intervention groups
Time Frame
6 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikard Landberg, PhD
Organizational Affiliation
Chalmers University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chalmers University of Technology
City
Gothenburg
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High Fiber Rye Foods for Body Weight and Body Fat Reduction

We'll reach out to this number within 24 hrs