Improvement of Metabolic Health After Thylakoid Supplementation
Metabolic Risk Markers and Body Weight Are Decreased by Green-plant Supplementation in a Pilot Study With Overweight-to-obese Middle-aged Men.
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Objective: The purpose of this study was to investigate the possible effects of green-plant thylakoid supplementation to a restricted diet intervention study in overweight to obese men. Methods: Overweight-obese men (BMI 25 - 35) were treated to a 30 E% restricted diet for one month, followed by one month of stabilization. Then they were divided in two treatment arms of one month each; one thylakoid-enriched diet (n=10) and one control diet (n=10). Body measurements and blood samples were taken throughout the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedFebruary 22, 2016
February 1, 2016
4 months
February 10, 2016
February 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight
3 months
Secondary Outcomes (5)
Waist circumference
3 months
Blood lipids
3 months
P-glucose and p-insulin
3 months
Inflammatory markers
3 months
Appetite regulating hormones
3 months
Study Arms (2)
Control group
PLACEBO COMPARATORControl group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component.
Thylakoid group
ACTIVE COMPARATORThylakoid group subjects received the same diet restriction intervention as the control group. However, their food products did contain an active component in the form of thylakoid powder.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy, overweight, non-vegetarian, non-smoking
You may not qualify if:
- Medication for metabolic disturbances, previous bariatric surgery, diabetes, had been on diet or treated with antibiotics during last 3 months, food-allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Lund Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva-Lena Stenblom, M.D.
Lund University, Region Skane
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
February 10, 2016
First Posted
February 22, 2016
Study Start
January 1, 2010
Primary Completion
May 1, 2010
Study Completion
January 1, 2016
Last Updated
February 22, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share