search
Back to results

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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Wholegrain rye
Refined wheat
Sponsored by
Swedish University of Agricultural Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

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

Sites / Locations

  • Chalmers University of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wholegrain rye

Refined wheat

Arm Description

Wholegrain rye products with a high content of dietary fiber

Refined wheat products with a low content of dietary fiber

Outcomes

Primary Outcome Measures

Difference in body weight
Difference in body fat mass

Secondary Outcome Measures

Appetite measured by visual analogue scale (VAS) questionnaire
Investigate if satiety differs between groups after 12 weeks of intervention and investigate if appetite correlates with changes in body weight. Measurements will be conducted through visual analogue scale (VAS) questionnaire, where participants log into a homepage and respond to their perceived satiety, hunger and desire to eat every 30-60 min during a day at base line, after 6w and 12wk.
Difference in body weight and body fat mass
Investigate if differences in body weight and body fat mass is evident already after 6 weeks
Fecal energy excretion by bomb calorimetry of 72h quantitative fecal collections.
Investigate differences in fecal energy excretion between the two intervention groups in a subgroup of 50 subjects. Every subject will be instructed to collect all feces in a special devise during 48h.
Gut microbiota
Marker of glucose metabolism
Investigate differences in hemoglobin A1c (HbA1c)
Marker of Insulin resistance
Investigate differences in homeostatic model assessment insulin resistance (HOMA-IR)
Appetite regulation
Investigate differences in glucagon-like peptide 1(GLP-1)
Appetite
Investigate differences in leptin concentration
Marker of inflammation
Investigate differences in C-reactive protein (CRP).
Blood lipids
Investigate differences in triglyceride (TG), total cholesterol, high density lipoprotein(HDL) and low density lipoprotein (LDL).

Full Information

First Posted
December 4, 2016
Last Updated
January 4, 2019
Sponsor
Swedish University of Agricultural Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03097237
Brief Title
High Fiber Rye Foods for Weight and Body Fat Reduction
Acronym
RyeWeight
Official Title
High Fiber Rye Foods for Weight and Body Fat Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swedish University of Agricultural Sciences

4. Oversight

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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Wholegrain rye
Arm Type
Experimental
Arm Description
Wholegrain rye products with a high content of dietary fiber
Arm Title
Refined wheat
Arm Type
Active Comparator
Arm Description
Refined wheat products with a low content of dietary fiber
Intervention Type
Other
Intervention Name(s)
Wholegrain rye
Intervention Description
Cereal products based on wholegrain rye
Intervention Type
Other
Intervention Name(s)
Refined wheat
Other Intervention Name(s)
Control
Intervention Description
Cereal products based on refined wheat
Primary Outcome Measure Information:
Title
Difference in body weight
Time Frame
12 weeks
Title
Difference in body fat mass
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Appetite measured by visual analogue scale (VAS) questionnaire
Description
Investigate if satiety differs between groups after 12 weeks of intervention and investigate if appetite correlates with changes in body weight. Measurements will be conducted through visual analogue scale (VAS) questionnaire, where participants log into a homepage and respond to their perceived satiety, hunger and desire to eat every 30-60 min during a day at base line, after 6w and 12wk.
Time Frame
12 weeks
Title
Difference in body weight and body fat mass
Description
Investigate if differences in body weight and body fat mass is evident already after 6 weeks
Time Frame
6 weeks
Title
Fecal energy excretion by bomb calorimetry of 72h quantitative fecal collections.
Description
Investigate differences in fecal energy excretion between the two intervention groups in a subgroup of 50 subjects. Every subject will be instructed to collect all feces in a special devise during 48h.
Time Frame
12 weeks
Title
Gut microbiota
Time Frame
6 and 12 weeks
Title
Marker of glucose metabolism
Description
Investigate differences in hemoglobin A1c (HbA1c)
Time Frame
6 and 12 weeks
Title
Marker of Insulin resistance
Description
Investigate differences in homeostatic model assessment insulin resistance (HOMA-IR)
Time Frame
6 and 12 weeks
Title
Appetite regulation
Description
Investigate differences in glucagon-like peptide 1(GLP-1)
Time Frame
6 and 12 weeks
Title
Appetite
Description
Investigate differences in leptin concentration
Time Frame
6 and 12 weeks
Title
Marker of inflammation
Description
Investigate differences in C-reactive protein (CRP).
Time Frame
6 and 12 weeks
Title
Blood lipids
Description
Investigate differences in triglyceride (TG), total cholesterol, high density lipoprotein(HDL) and low density lipoprotein (LDL).
Time Frame
6 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikard Landberg, Dr
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

Citations:
PubMed Identifier
34620312
Citation
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.
Results Reference
derived

Learn more about this trial

High Fiber Rye Foods for Weight and Body Fat Reduction

We'll reach out to this number within 24 hrs