Improvement of Metabolic Health After Thylakoid Supplementation

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Obesity

• Registration Number: NCT02687295
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2010-05
• Study Completion: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight	3 months

Secondary Outcome Measures

Name	Time	Method
Blood lipids	3 months	Total cholesterol, LDL, HDL and TAG are measured fasting every fourth week.
Inflammatory markers	3 months	CRP and TNF alpha are measured fasting every fourth week.
Appetite regulating hormones	3 months	Ghrelin and leptin are measured fasting every fourth week.
Waist circumference	3 months
P-glucose and p-insulin	3 months	P-glucose, p-insulin and HbA1c are measured fasting every fourth week.