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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
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    February 10, 2016
    Last Updated
    February 16, 2016
    Sponsor
    Region Skane
    Collaborators
    Lund University
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    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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