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Improvement of Metabolic Health After Thylakoid Supplementation

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ClinicalTrials.gov Identifier: NCT02687295
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Eva-Lena Stenblom, Region Skane

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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Dietary Supplement: Thylakoids Other: Control Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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 Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
Control group subjects received the same diet restriction intervention as treatment group. However, their food products did not contain any active component.
Other: Control
Other Name: Placebo

Active Comparator: Thylakoid group
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.
Dietary Supplement: Thylakoids
Other Names:
  • Appethyl
  • Green-plant membranes




Primary Outcome Measures :
  1. Body weight [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Waist circumference [ Time Frame: 3 months ]
  2. Blood lipids [ Time Frame: 3 months ]
    Total cholesterol, LDL, HDL and TAG are measured fasting every fourth week.

  3. P-glucose and p-insulin [ Time Frame: 3 months ]
    P-glucose, p-insulin and HbA1c are measured fasting every fourth week.

  4. Inflammatory markers [ Time Frame: 3 months ]
    CRP and TNF alpha are measured fasting every fourth week.

  5. Appetite regulating hormones [ Time Frame: 3 months ]
    Ghrelin and leptin are measured fasting every fourth week.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687295


Sponsors and Collaborators
Region Skane
Lund University
Investigators
Principal Investigator: Eva-Lena Stenblom, M.D. Lund University, Region Skane

Responsible Party: Eva-Lena Stenblom, M.D., Region Skane
ClinicalTrials.gov Identifier: NCT02687295     History of Changes
Other Study ID Numbers: Gubbar-2010
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases