Duckweed Intake Study

NCT03677583 | Completed

• 1 other identifier: NL66051.081.18
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to study the impact of frequent intake of 150-180 gram duckweed on gastrointestinal complaints and several other health related biomarkers. The study has a randomised parallel design. Two different treatments will be evaluated e.g. a 11-day intervention with duckweed based meals and a 11-day intervention with control/spinach meals. At the start and at the end of the intervention we will collect a blood sample and a urine samples. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.

Conditions

Gastrointestinal Complication

Outcome Measures

Primary Outcomes (1)

• change in gastro-intestinal complaints

  bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation measured via Visual Analogue Scale (VAS)

  Daily, during 11 days of duckweed intake and up to three days after intake. By questionnaires and Visual Analogue Scale (VAS) scores; from no complains (minimal) to serious complains (maximum)). Higher values represent a worse outcome

Secondary Outcomes (12)

• change in blood hemoglobin

  before (D=0) and after (D=11) 11 days of duckweed or spinach intake

• change in blood glucose

  before (D=0) and after (D=11) 11 days of duckweed or spinach intake

• change in blood Fe (Iron)

  before (D=0) and after (D=11) 11 days of duckweed or spinach intake

• change in blood leukocyte cell counts

  before (D=0) and after (D=11) 11 days of duckweed or spinach intake

• change in blood ALAT

  before (D=0) and after (D=11) 11 days of duckweed or spinach intake

Other Outcomes (1)

• fiber, fruit and vegetable intake

  before the intervention (D=0), this questionaire provides insights in energy and macronutrient consumption

Study Arms (2)

Duckweed

EXPERIMENTAL

daily lunch with 150-180g wet weight duck weed

Other: Duckweed

Spinach

ACTIVE COMPARATOR

daily lunch with 150-180g wet weight spinach

Other: Spinach

Interventions

Duckweed OTHER

various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce

Duckweed

Spinach OTHER

various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce

Spinach

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy men and women
• Age between 18 and 50 years
• Body mass index (BMI) between 18.5 and 24.9 kg/m2

You may not qualify if:

• Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
• History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
• History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
• Kidney dysfunction (self-reported)
• Use of medication that may influence the study results, such as gastric acid inhibitors or laxatives
• Reported slimming, medically prescribed or vegan/vegetarian diet
• Current smokers
• Alcohol intake ≥4 glasses of alcoholic beverages per day
• Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
• Abuse of illicit drugs
• Food allergies for products that we use in the study
• Participation in another clinical trial at the same time
• Being an employee of the department Consumer Science \& Health group of Wageningen Food \& Biobased Research

Sponsors & Collaborators

• Wageningen University and Research: lead

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Study Officials

• Diederik Esser, Dr

  Wageningen research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: project leader clinical trials

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 19, 2018
• Study Start: October 1, 2018
• Primary Completion: October 14, 2018
• Study Completion: October 15, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)