NCT03097237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

December 4, 2016

Last Update Submit

January 4, 2019

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (2)

  • Difference in body weight

    12 weeks

  • Difference in body fat mass

    12 weeks

Secondary Outcomes (10)

  • Appetite measured by visual analogue scale (VAS) questionnaire

    12 weeks

  • Difference in body weight and body fat mass

    6 weeks

  • Fecal energy excretion by bomb calorimetry of 72h quantitative fecal collections.

    12 weeks

  • Gut microbiota

    6 and 12 weeks

  • Marker of glucose metabolism

    6 and 12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Wholegrain rye

EXPERIMENTAL

Wholegrain rye products with a high content of dietary fiber

Other: Wholegrain rye

Refined wheat

ACTIVE COMPARATOR

Refined wheat products with a low content of dietary fiber

Other: Refined wheat

Interventions

Wholegrain ryeOTHER

Cereal products based on wholegrain rye

Wholegrain rye
Refined wheatOTHER

Cereal products based on refined wheat

Also known as: Control
Refined wheat

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chalmers University of Technology

Gothenburg, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 34620312DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rikard Landberg, Dr

    Chalmers University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 4, 2016

First Posted

March 31, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

SE(1)