Improvement of Metabolic Health After Thylakoid Supplementation
Primary Purpose
Metabolic Syndrome, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thylakoids
Control
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Healthy, overweight, non-vegetarian, non-smoking
Exclusion Criteria:
- Medication for metabolic disturbances, previous bariatric surgery, diabetes, had been on diet or treated with antibiotics during last 3 months, food-allergies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control group
Thylakoid group
Arm Description
Control group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component.
Thylakoid 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.
Outcomes
Primary Outcome Measures
Body weight
Secondary Outcome Measures
Waist circumference
Blood lipids
Total cholesterol, LDL, HDL and TAG are measured fasting every fourth week.
P-glucose and p-insulin
P-glucose, p-insulin and HbA1c are measured fasting every fourth week.
Inflammatory markers
CRP and TNF alpha are measured fasting every fourth week.
Appetite regulating hormones
Ghrelin and leptin are measured fasting every fourth week.
Full Information
NCT ID
NCT02687295
First Posted
February 10, 2016
Last Updated
February 16, 2016
Sponsor
Region Skane
Collaborators
Lund University
1. Study Identification
Unique Protocol Identification Number
NCT02687295
Brief Title
Improvement of Metabolic Health After Thylakoid Supplementation
Official Title
Metabolic Risk Markers and Body Weight Are Decreased by Green-plant Supplementation in a Pilot Study With Overweight-to-obese Middle-aged Men.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Lund University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Twenty healthy, non-vegetarian, non-smoking Caucasian men were included in the study. Inclusion criteria: men aged 40 to 70 years with a BMI of 25 to 35. Exclusion criteria: Metabolic disturbances, bariatric surgery, recent diet, food allergies or treatment with antibiotics. The study protocol was approved by the Ethical Committee of Lund University, Sweden (#2006/361).
The trial consisted of three periods: 1) diet-restriction period (one month) 2) stabilizing period (one month) 3) diet-restriction period with supplementation of thylakoids or placebo (one month). The two weight-losing periods included strict diet recommendation with -30 energy % (E%), and macronutrient composition: 55-65 E% carbohydrates, 10-15 E% protein and 25-35 E% fat. Sixty minutes of low intensive exercise per day was also required.
During the stabilizing month participants were instructed to eat a healthy diet to be able to keep their achieved weight-loss.
Day 0, 28, 56 and 84 the participants arrived after 12-hour fasting for blood sampling and anthropometric measurements. The blood samples were analyzed for plasma-glucose, insulin, HbA1c, inflammation markers, cholecystokinin, ghrelin, total cholesterol, LDL-cholesterol, HDL-cholesterol, and triacylglycerol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component.
Arm Title
Thylakoid group
Arm Type
Active Comparator
Arm Description
Thylakoid 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Thylakoids
Other Intervention Name(s)
Appethyl, Green-plant membranes
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Body weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Waist circumference
Time Frame
3 months
Title
Blood lipids
Description
Total cholesterol, LDL, HDL and TAG are measured fasting every fourth week.
Time Frame
3 months
Title
P-glucose and p-insulin
Description
P-glucose, p-insulin and HbA1c are measured fasting every fourth week.
Time Frame
3 months
Title
Inflammatory markers
Description
CRP and TNF alpha are measured fasting every fourth week.
Time Frame
3 months
Title
Appetite regulating hormones
Description
Ghrelin and leptin are measured fasting every fourth week.
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, overweight, non-vegetarian, non-smoking
Exclusion Criteria:
Medication for metabolic disturbances, previous bariatric surgery, diabetes, had been on diet or treated with antibiotics during last 3 months, food-allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva-Lena Stenblom, M.D.
Organizational Affiliation
Lund University, Region Skane
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Improvement of Metabolic Health After Thylakoid Supplementation
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