Clinical trial NCT02687295: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2016-02-22
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Body weight
timeFrame: 3 months
Secondary outcomes:
measure: Waist circumference
timeFrame: 3 months
measure: Blood lipids
timeFrame: 3 months
measure: P-glucose and p-insulin
timeFrame: 3 months
measure: Inflammatory markers
timeFrame: 3 months
measure: Appetite regulating hormones
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Lund University, Region Skane
name: Eva-Lena Stenblom, M.D.
role: PRINCIPAL_INVESTIGATOR
References: