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Goji Berries and Energy Expenditure

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Lycium Barbarum mixed meal
Control mixed meal
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Lycium Barbarum, Energy expenditure, Postprandial metabolism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male gender
  • BMI between 25 and 30 kg/m2
  • Non-smoking
  • Normal fasting triacylglycerol levels (<2.2 mmol/L)
  • No hyperglycaemia or hypercholesterolemia (fasting glucose < 7.0 mmol/L and total cholesterol < 8.0 mmol/L)
  • Willing to comply to the study protocol during the study
  • Agreeing to be informed about medically relevant personal test-results

Exclusion Criteria:

  • Use of anticoagulant medication
  • Unstable body weight (weight gain or loss >3 kg in the past 3 months)
  • Indications of treatment according to the Standard for Cardiovascular Risk Management from the Dutch General Practitioners community
  • Any medical condition that might interfere with study measurements, judged by the principal investigator, including cardiovascular disease or events (e.g. acute myocardial infarction or cerebra-vascular accident), diabetes or hypercholesterolemia
  • Use of any kind of medication or medically prescribed diet, which can interfere with the study (judged by the principal investigator). The use of paracetamol is allowed
  • Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to the start of the study
  • Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three weeks prior to the screening and/or during the study
  • Not willing to abstain from L. Barbarum consumption thee weeks before the start and during the trial
  • Severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease and rheumatoid arthritis
  • Consumption of > 14 alcohol consumptions a week
  • Reported intense sporting activities > 10 hours a week
  • Abuse of drugs
  • Participation in any other biomedical trial one month prior to the screening visit
  • Having donated > 150 ml blood within 1 month prior to the screening visit, planning to donate blood during the study or within one month after finishing the study
  • Impossible or difficult to puncture as evidenced during the screening visit

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lycium Barbarum mixed meal

Control mixed meal

Arm Description

Subjects will receive a high-fat mixed meal containing Lycium Barbarum once.

Subjects will receive a high-fat mixed meal without Lycium Barbarum as a control.

Outcomes

Primary Outcome Measures

Change from baseline energy expenditure
Energy expenditure will be measured using indirect calorimetry (ventilated hood system). This system measures oxygen consumption (VO2) and carbon dioxide production (VCO2) to calculate the energy expenditure (kJ/min)

Secondary Outcome Measures

Change from baseline energy expenditure
Energy expenditure will be measured using indirect calorimetry (ventilated hood system). This system measures VO2 and VCO2 to calculate the energy expenditure (kJ/min).
Postprandial lipid and glucose oxidation
Lipid and glucose oxidation will be calculated from indirect calorimetry data (VO2 and VCO2).
Metabolic flexibility
Metabolic flexibility will be derived from indirect calorimetry as the difference in respiratory quotient (RQ) between fasting and postprandial conditions.
Markers for lipid metabolism
Several markers for lipid metabolism will be measured in blood samples.
Markers for glucose metabolism
Several markers for glucose metabolism will be measured in blood samples.
Inflammatory status
Several markers for inflammatory status will be measured in blood samples and in vitro conditions

Full Information

First Posted
April 18, 2016
Last Updated
January 31, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02779985
Brief Title
Goji Berries and Energy Expenditure
Official Title
The Effect of a Single Dose of Lycium Barbarum on Postprandial Energy Expenditure in Healthy Overweight Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

5. Study Description

Brief Summary
Effects of foods or food substances on energy expenditure are of particular interest, because of the increasing prevalence of obesity and its consequent metabolic diseases like type II diabetes and fatty liver disease, all risk factors for the development of cardiovascular diseases (CVDs). Recently, the Goji berry (Lycium Barbarum, wolfberry) was introduced into the Western diet. L. Barbarum originates from Asia, where it is used to improve the health of several organs. Although L. Barbarum is promoted as a super food with many beneficial effects, consistent scientific evidence for these effects is lacking. In one study, it was found that short-term intake of L. Barbarum polysaccharides - equal to 150 g of fresh berries - increased postprandial oxygen consumption. This indicates that L. Barbarum might exert beneficial effects on energy expenditure. Furthermore, long-term intervention trials have shown beneficial effects of L. Barbarum on lipid and glucose metabolism in mice and type II diabetic patients and on inflammatory status in healthy elderly. Altogether, L. Barbarum has the potential to be used as a functional food to increase metabolic health, but detailed information on the postprandial effects of L. Barbarum is missing. We therefore propose this double-blinded, randomized, placebo controlled intervention trial to investigate the effect of a single dose of L. Barbarum on postprandial energy expenditure substrate oxidation, metabolic flexibility, lipid and glucose metabolism and inflammatory markers.
Detailed Description
Objectives: The primary objective of this study is to investigate the effect of a single dose of L. Barbarum on postprandial energy expenditure. Secondary objectives are to investigate the effect of a single dose of L. Barbarum on postprandial lipid and carbohydrate oxidation and metabolic flexibility, on postprandial lipid and glucose metabolism and on inflammatory markers. Study design: This is a double blind, randomized, placebo-controlled intervention trial with two test days separated by a washout period of at least 1 week. Study population: The study population will consist of 20 apparently healthy overweight (BMI between 25 and 30 kg/m2) men aged 18-65 years. Intervention: All subjects will receive a mixed meal including 25 grams of dried L. Barbarum as the intervention product and a matched mixed meal without L. Barbarum as the placebo product. The meals will be matched for energy content and macronutrient composition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Lycium Barbarum, Energy expenditure, Postprandial metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lycium Barbarum mixed meal
Arm Type
Experimental
Arm Description
Subjects will receive a high-fat mixed meal containing Lycium Barbarum once.
Arm Title
Control mixed meal
Arm Type
Active Comparator
Arm Description
Subjects will receive a high-fat mixed meal without Lycium Barbarum as a control.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lycium Barbarum mixed meal
Intervention Description
This mixed meal contains 25 grams of dried Lycium Barbarum (Goji berry, Wolfberry)
Intervention Type
Dietary Supplement
Intervention Name(s)
Control mixed meal
Intervention Description
This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content
Primary Outcome Measure Information:
Title
Change from baseline energy expenditure
Description
Energy expenditure will be measured using indirect calorimetry (ventilated hood system). This system measures oxygen consumption (VO2) and carbon dioxide production (VCO2) to calculate the energy expenditure (kJ/min)
Time Frame
Measured as the incremental area under the curve (iAUC) from 0 minutes to 140 minutes after meal intake
Secondary Outcome Measure Information:
Title
Change from baseline energy expenditure
Description
Energy expenditure will be measured using indirect calorimetry (ventilated hood system). This system measures VO2 and VCO2 to calculate the energy expenditure (kJ/min).
Time Frame
Measured as the incremental area under the curve (iAUC) from 160 minutes to 200 minutes and from 220 minutes to 260 minutes after meal intake
Title
Postprandial lipid and glucose oxidation
Description
Lipid and glucose oxidation will be calculated from indirect calorimetry data (VO2 and VCO2).
Time Frame
At baseline (T0, fasting) and between 0 minutes and 140 minutes, between 160 minutes and 200 minutes and between 220 minutes and 260 minutes after meal consumption
Title
Metabolic flexibility
Description
Metabolic flexibility will be derived from indirect calorimetry as the difference in respiratory quotient (RQ) between fasting and postprandial conditions.
Time Frame
At 60, 120, 180 and 240 minutes after meal intake
Title
Markers for lipid metabolism
Description
Several markers for lipid metabolism will be measured in blood samples.
Time Frame
At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
Title
Markers for glucose metabolism
Description
Several markers for glucose metabolism will be measured in blood samples.
Time Frame
At baseline (T0) and at regular intervals up to 240 minutes after meal consumption
Title
Inflammatory status
Description
Several markers for inflammatory status will be measured in blood samples and in vitro conditions
Time Frame
At baseline (T0) and at 60, 120, 180 and 240 minutes after meal consumption

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male gender BMI between 25 and 30 kg/m2 Non-smoking Normal fasting triacylglycerol levels (<2.2 mmol/L) No hyperglycaemia or hypercholesterolemia (fasting glucose < 7.0 mmol/L and total cholesterol < 8.0 mmol/L) Willing to comply to the study protocol during the study Agreeing to be informed about medically relevant personal test-results Exclusion Criteria: Use of anticoagulant medication Unstable body weight (weight gain or loss >3 kg in the past 3 months) Indications of treatment according to the Standard for Cardiovascular Risk Management from the Dutch General Practitioners community Any medical condition that might interfere with study measurements, judged by the principal investigator, including cardiovascular disease or events (e.g. acute myocardial infarction or cerebra-vascular accident), diabetes or hypercholesterolemia Use of any kind of medication or medically prescribed diet, which can interfere with the study (judged by the principal investigator). The use of paracetamol is allowed Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to the start of the study Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three weeks prior to the screening and/or during the study Not willing to abstain from L. Barbarum consumption thee weeks before the start and during the trial Severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease and rheumatoid arthritis Consumption of > 14 alcohol consumptions a week Reported intense sporting activities > 10 hours a week Abuse of drugs Participation in any other biomedical trial one month prior to the screening visit Having donated > 150 ml blood within 1 month prior to the screening visit, planning to donate blood during the study or within one month after finishing the study Impossible or difficult to puncture as evidenced during the screening visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Mensink, Professor
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jogchum Plat, Professor
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 ER
Country
Netherlands

12. IPD Sharing Statement

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Goji Berries and Energy Expenditure

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