Goji Berries and Energy Expenditure

NCT02779985 | Completed

• 1 other identifier: METC 15-3-060
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Keywords

Lycium Barbarum; Energy expenditure; Postprandial metabolism

Outcome Measures

Primary Outcomes (1)

• 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)

  Measured as the incremental area under the curve (iAUC) from 0 minutes to 140 minutes after meal intake

Secondary Outcomes (6)

• Change from baseline energy expenditure

  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

• Postprandial lipid and glucose oxidation

  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

• Metabolic flexibility

  At 60, 120, 180 and 240 minutes after meal intake

• Markers for lipid metabolism

  At baseline (T0) and at regular intervals up to 240 minutes after meal consumption

• Markers for glucose metabolism

  At baseline (T0) and at regular intervals up to 240 minutes after meal consumption

Study Arms (2)

Lycium Barbarum mixed meal

EXPERIMENTAL

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

Dietary Supplement: Lycium Barbarum mixed meal

Control mixed meal

ACTIVE COMPARATOR

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

Dietary Supplement: Control mixed meal

Interventions

Lycium Barbarum mixed meal DIETARY_SUPPLEMENT

This mixed meal contains 25 grams of dried Lycium Barbarum (Goji berry, Wolfberry)

Lycium Barbarum mixed meal

Control mixed meal DIETARY_SUPPLEMENT

This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content

Control mixed meal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald Mensink, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Jogchum Plat, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: May 23, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2016-04

Locations

NL (1)