ObesityRyeWeight2NCT04203758
High Fiber Rye Foods for Body Weight and Body Fat Reduction
A study testing Cereal products based on rye and Cereal products based on wheat in people with Obesity and Overweight, run by Chalmers University of Technology at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Cereal products based on rye and Cereal products based on wheat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2020to 8 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity, Overweight
- Being tested
- Cereal products based on rye, Cereal products based on wheat
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereal products based on ryeOther
Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.
Cereal products based on wheatOther
Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.
| Study group | Role | What they receive |
|---|---|---|
| Wholegrain rye products with a high content of dietary fiber | Experimental | Cereal products based on wholegrain rye Receives: Other: Cereal products based on rye |
| Refined wheat products with a low content of dietary fiber | Active comparator | Cereal products based on refined wheat Receives: Other: Cereal products based on wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate if there is a difference in body weight at week 12
Measured on a scale
Measured: 12 weeks
Investigate if there is a difference in body fat mass at week 12
Measured by dual energy x-ray absorptiometry
Measured: 12 weeks
Secondary outcomes (16)
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.
Measured: 0 weeks, 6 weeks and 12 weeks.
Investigate if differences in primary endpoints (body weight) are apparent at week 6
Measured on a scale
Measured: 6 weeks
Investigate if differences in primary endpoints (fat mass) are apparent at week 6
Measured by dual energy x-ray absorptiometry
Measured: 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
Measured: 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
Measured: 6 weeks and 12 weeks
Investigate if fasting plasma triglycerides differ between groups
Measured: 6 weeks and 12 weeks
Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups
Measured: 6 weeks and 12 weeks
Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups
Measured: 6 weeks and 12 weeks
Investigate if fasting plasma total cholesterol differ between groups
Measured: 6 weeks and 12 weeks
Investigate if fasting plasma glucose differ between groups
Measured: 6 weeks and 12 weeks
Investigate if fasting serum insulin differ between groups
Measured: 6 weeks and 12 weeks
Investigate if C-reactive protein differ between groups
Measured: 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
Measured: 6 weeks and 12 weeks
Investigate if hip circumference differ between intervention groups
Measured: 6 weeks and 12 weeks
Investigate if waist circumference differ between intervention
Measured: 6 weeks and 12 weeks
Investigate if sagittal height differ between intervention groups
Measured: 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start20 Jan 2020
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, PhD, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203758
- Sponsor's protocol ID
- RW2
- Acronym
- RyeWeight2
- Status last verified
- Jul 2021
- First submitted
- 13 Dec 2019
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aberg S, Nordin E, Iversen KN, Qin P, Hellstrom PM, Kristiansen K, Landberg R. Effects of hypocaloric wholegrain rye vs refined wheat diets on weight loss, cardiometabolic risk factors and gut microbiota: A 12-week randomized controlled trial. Clin Nutr. 2026 May;60:106618. doi: 10.1016/j.clnu.2026.106618. Epub 2026 Mar 9.
PubMed 41861447
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Fiber Rye Foods for Body Weight and Body Fat Reduction - The RyeWeight2 Study, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04203758
- Acronym / sponsor ID
- RyeWeight2 / RW2
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wholegrain rye products with a high content of dietary fiber | Experimental | Other: Cereal products based on ryeCereal products based on wholegrain rye |
| Refined wheat products with a low content of dietary fiber | Active comparator | Other: Cereal products based on wheatCereal products based on refined wheat |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cereal products based on ryeParticipants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day. | Other | Wholegrain rye products with a high content of dietary fiber |
| Cereal products based on wheatParticipants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day. | Other | Refined wheat products with a low content of dietary fiber |
Primary outcome
Investigate if there is a difference in body weight at week 12
Time frame: 12 weeks
Measured on a scale
Investigate if there is a difference in body fat mass at week 12
Time frame: 12 weeks
Measured by dual energy x-ray absorptiometry
16 secondary outcomes
Investigate if there are differences in subjective appetite ratings
Time frame: 0 weeks, 6 weeks and 12 weeks.
Investigate if differences in primary endpoints (body weight) are apparent at week 6
Time frame: 6 weeks
Investigate if differences in primary endpoints (fat mass) are apparent at week 6
Time frame: 6 weeks
Investigate if lean body mass differs between intervention groups after 6 and 12 weeks of intervention
Time frame: 6 weeks and 12 weeks
Investigate if abdominal fat mass differs between intervention groups after 6 and 12 weeks of intervention
Time frame: 6 weeks and 12 weeks
Investigate if fasting plasma triglycerides differ between groups
Time frame: 6 weeks and 12 weeks
Investigate if fasting plasma low-density lipoprotein cholesterol differ between groups
Time frame: 6 weeks and 12 weeks
Investigate if fasting plasma high-density lipoprotein cholesterol differ between groups
Time frame: 6 weeks and 12 weeks
Investigate if fasting plasma total cholesterol differ between groups
Time frame: 6 weeks and 12 weeks
Investigate if fasting plasma glucose differ between groups
Time frame: 6 weeks and 12 weeks
Investigate if fasting serum insulin differ between groups
Time frame: 6 weeks and 12 weeks
Investigate if C-reactive protein differ between groups
Time frame: 6 weeks and 12 weeks
Investigate if gut microbiota composition is affected by the intervention
Time frame: 6 weeks and 12 weeks
Investigate if hip circumference differ between intervention groups
Time frame: 6 weeks and 12 weeks
Investigate if waist circumference differ between intervention
Time frame: 6 weeks and 12 weeks
Investigate if sagittal height differ between intervention groups
Time frame: 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Derived from this study: PubMed 41861447Aberg S, Nordin E, Iversen KN, Qin P, Hellstrom PM, Kristiansen K, Landberg R. Effects of hypocaloric wholegrain rye vs refined wheat diets on weight loss, cardiometabolic risk factors and gut microbiota: A 12-week randomized controlled trial. Clin Nutr. 2026 May;60:106618. doi: 10.1016/j.clnu.2026.106618. Epub 2026 Mar 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikard Landberg, PhD principal investigator
Chalmers University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereal products based on rye and Cereal products based on wheat in people with Obesity and Overweight, run by Chalmers University of Technology at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate if there is a difference in body weight at week 12 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.