OverweightRyeWeightNCT03097237
High Fiber Rye Foods for Weight and Body Fat Reduction
A study testing Wholegrain rye and Refined wheat in people with Overweight and Obesity, run by Swedish University of Agricultural Sciences 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 hypocaloric 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
- Overweight, Obesity
- What is being tested?
- Wholegrain rye and Refined wheat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to Dec 2018
- 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
- 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
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 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)
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Wholegrain rye, Refined wheat
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wholegrain ryeOther
Cereal products based on wholegrain rye
Refined wheatOther
Also called Control
Cereal products based on refined wheat
| Study group | Role | What they receive |
|---|---|---|
| Wholegrain rye | Experimental | Wholegrain rye products with a high content of dietary fiber Receives: Other: Wholegrain rye |
| Refined wheat | Active comparator | Refined wheat products with a low content of dietary fiber Receives: Other: Refined wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in body weight
Measured: 12 weeks
Difference in body fat mass
Measured: 12 weeks
Secondary outcomes (10)
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.
Measured: 12 weeks
Difference in body weight and body fat mass
Investigate if differences in body weight and body fat mass is evident already after 6 weeks
Measured: 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.
Measured: 12 weeks
Gut microbiota
Measured: 6 and 12 weeks
Marker of glucose metabolism
Investigate differences in hemoglobin A1c (HbA1c)
Measured: 6 and 12 weeks
Marker of Insulin resistance
Investigate differences in homeostatic model assessment insulin resistance (HOMA-IR)
Measured: 6 and 12 weeks
Appetite regulation
Investigate differences in glucagon-like peptide 1(GLP-1)
Measured: 6 and 12 weeks
Appetite
Investigate differences in leptin concentration
Measured: 6 and 12 weeks
Marker of inflammation
Investigate differences in C-reactive protein (CRP).
Measured: 6 and 12 weeks
Blood lipids
Investigate differences in triglyceride (TG), total cholesterol, high density lipoprotein(HDL) and low density lipoprotein (LDL).
Measured: 6 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 posted31 Mar 2017
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
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 OverweightStudies 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish University of Agricultural Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, Dr, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097237
- Sponsor's protocol ID
- SLU254
- Acronym
- RyeWeight
- Status last verified
- Jan 2019
- First submitted
- 4 Dec 2016
- Last updated
- 8 Jan 2019
- Results posted
- No
Publications
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.
PubMed 34620312
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Fiber Rye Foods for Weight and Body Fat Reduction
- ClinicalTrials.gov ID
- NCT03097237
- Acronym / sponsor ID
- RyeWeight / SLU254
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Swedish University of Agricultural SciencesUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 31 Mar 2017 (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 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.
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 | Experimental | Other: Wholegrain ryeWholegrain rye products with a high content of dietary fiber |
| Refined wheat | Active comparator | Other: Refined wheatRefined wheat products with a low content of dietary fiber |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 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 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.)
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 |
|---|---|---|
| Wholegrain ryeCereal products based on wholegrain rye | Other | Wholegrain rye |
| Refined wheatAlso: ControlCereal products based on refined wheat | Other | Refined wheat |
Primary outcome
Difference in body weight
Time frame: 12 weeks
Difference in body fat mass
Time frame: 12 weeks
10 secondary outcomes
Appetite measured by visual analogue scale (VAS) questionnaire
Time frame: 12 weeks
Difference in body weight and body fat mass
Time frame: 6 weeks
Fecal energy excretion by bomb calorimetry of 72h quantitative fecal collections.
Time frame: 12 weeks
Gut microbiota
Time frame: 6 and 12 weeks
Marker of glucose metabolism
Time frame: 6 and 12 weeks
Marker of Insulin resistance
Time frame: 6 and 12 weeks
Appetite regulation
Time frame: 6 and 12 weeks
Appetite
Time frame: 6 and 12 weeks
Marker of inflammation
Time frame: 6 and 12 weeks
Blood lipids
Time frame: 6 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 8 Jan 2019.
- Derived from this study: PubMed 34620312Iversen 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.
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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, Dr 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 Wholegrain rye and Refined wheat in people with Overweight and Obesity, run by Swedish University of Agricultural Sciences 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 7 inclusion and 24 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 8 Jan 2019. 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?
Difference in body weight (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 NCT03097237, 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 8 Jan 2019.