Health, SubjectiveRIGHTWHEYNCT03844152
RIGHTWHEY - Responders In Gut HealTh Markers Using Fermented WHEY
A study testing Fermented whey concentrate in people with Health, Subjective and Healthy, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This 8-week intervention will investigate the effect of daily consumption of a fermented whey concentrate on the short-chain fatty acid profile of faeces in healthy individuals. This study will help us understand if consumption of fermented foods rich in lactic acid have a beneficial effect on gut health. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective, Healthy, Microbial Colonization
- What is being tested?
- Fermented whey concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Mar 2019to 8 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- i. Men and women aged 18-68 years; BMI ranging from 18-35 kg/m2; measured at the screening visit
Who cannot join
- i. smokers
- ii. subjects with: diagnosis of diabetes, pregnant, hypertension, renal, hepatic, haematological disease, coronary heart disease or any gastrointestinal disorder
- ii. unsuitable veins for blood sampling;
- iii. inability to speak, read and understand English.
- iv. Use of antibiotics within the last 3 months will automatically exclude volunteers.
- v. Vegans. Fermented whey concentrate, (FWC), is derived from milk (animal product) which excludes potential participants adhering to a vegan diet.
- vi. allergy to any of the following: cow milk, lactose, casein, whey, sucralose, acesulfame K, citric acid, potassium benzoate, fruit flavourings.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Rowett Institute, Human Nutrition Unit
Aberdeen, AB25 2ZD
About this study
Official title: Investigating the Effect of Fermented Whey Concentrate on Gut Microbial Activity: Does Butyrate Matter?
This 8-week intervention will investigate the effect of daily consumption of a fermented whey concentrate on the short-chain fatty acid profile of faeces in healthy individuals.
This study will help us understand if consumption of fermented foods rich in lactic acid have a beneficial effect on gut health.
Read the detailed description
The 8-week dietary supplementation trial will investigate the action of exogenous lactic acid consumption on the activity (using short-chain fatty acid) and composition of the gut microbiota.
Participants will be stratified according to their baseline faecal butyrate levels. Therefore volunteers will be asked to provide two faecal samples one week apart. Based on the average absolute level of butyrate in the faecal samples, volunteers will be stratified into either low, moderate or high baseline butyrate levels (detailed in table 1 below). The levels for faecal butyrate for each group are set based on a meta-analysis of 9 human studies of healthy volunteers carried out at the Rowett Institute (n=116; LaBouyer et al, 2016, unpublished). Thresholds were derived from the boundaries of tertiles. Therefore, the moderate butyrate producers represent the middle 33% (see table). Each stratification arm will have a minimum of 17 study volunteers bringing the total to n=51. This has been set to ensure the completion of at least 45 volunteers. To optimise equal gender distribution amongst all study arms a minimum of 5 females and 5 males will be recruited for each arm.
Stratification Butyrate range Low ≤13 mM Moderate butyrate 13 - 20mM High butyrate ≥20mM
Primary and secondary outcomes will be analysed between the low and high butyrate producing groups as well as the overall group effect on everyone.
- Conditions
- Health, Subjective, Healthy, Microbial Colonization
- Being tested
- Fermented whey concentrate
- Keywords
- fermented whey, microbiota, gut health, butyrate
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented whey concentrateDietary supplement
Also called Molkosan
The investigated dietary supplement is a form of lacto-fermented whey concentrate (FWC), which has been deproteinised and then diluted (1/20) in sugar-free flavoured water to improve palatability. The main solute within the lacto-fermented whey is L-(+)-lactic acid (7%), produced through bacterial fermentation of the milk sugar lactose. The research team will provide non-descriptive bottles of drink to all volunteers. The flavour of the FWC will be masked by the flavoured water. In order to assess compliance and minimize an initial treatment effect, a 14 day run-in period during which only flavoured water is to be consumed will be completed by all volunteers. At the same time, this period will act as a wash-out, as volunteers will be asked to abstain from the use of any dietary supplements during this period and the rest of the study. The daily energy content of the FWC is 4kcal.
| Study group | Role | What they receive |
|---|---|---|
| Fermented whey concentrate | Experimental | Volunteers will receive the premixed water and fermented whey in weekly deliveries in 1.5L bottles and a drinking glass with a clear indication of the required 200ml volume. Participants will be asked to drink 200 ml of the supplemented water twice daily for the active intervention period. Receives: Dietary Supplement: Fermented whey concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal butyrate concentration - comparing upper and lower tertile of volunteers
Change in relative proportion of butyrate (percentage of total SCFA - sum of propionate, butyrate, acetate, valerate, iso-valerate, iso-butyrate, succinate, lactate mM (millimolar values from gas chromatography) and absolute concentration (mM millimolar) when comparing volunteers as stratified by faecal butyrate levels at start of study. A comparison will be made between the butyrate concentration-dependent groupings.
Measured: Baseline measurement (Visit 1) and end of study (visit 3, 8 weeks later) [Baseline butyrate calculated from the average of two values per individual at Day -7 and Day 0; End of study value is the average from two samples collected at Day 49 and 56
Faecal butyrate concentration - intervention group effect
Change in relative proportion of butyrate (percentage of total SCFA) and absolute concentration (mM, millimolar) across the total study group
Measured: Baseline measurement (Visit 1) and end of study (visit 3, 8 weeks later) [Baseline butyrate calculated from the average of two values per individual at Day -7 and Day 0; End of study value is the average from two samples collected at Day 49 and 56
Microbiota composition change
Changes in the composition of the microbiota will be based on next-generation sequence analysis of 16S rRNA (ribosomal ribonucleic acid) genes extracted from faecal samples provided by all volunteers
Measured: Assessed as change between day 0 and day 56
Secondary outcomes (6)
Gastrointestinal wellness questionnaire
Changes in frequency or consistency of bowel movements and gastrointestinal well being will be assessed with a self-administered weekly questionnaire (ranked on a linear likert scale).
The questionnaire asks volunteers to rank nausea, bloating, flatulence, abdominal cramps, rumbling, indigestion, fullness/distension and early satiation over the last 24 hours. The scale is scored from -3 being considerably less, -2 moderately less, -1 for slightly less and 0 for as usual. Responses such as slightly more are scored as 1, moderately more as 2 and considerately more as 3.
Scores will be aggregated across all categories and compared as a whole to represent general GI wellness changing throughout the intervention.
Participants have a blank box to fill in with the number of bowel movements in the last 24hr and are asked to rank them on the Bristol stool scale (0-7, visual guide included in the questionnaire). Scores will be assessed as averages over the control and intervention periods.
Measured: Day 0, 7, 14, 21, 28, 35, 42, 49 and 56
Glucose tolerance and insulin sensitivity
Comparison of change in response to Oral glucose tolerance test (3 hours) using the total and incremental area under the curve (AUC)for both glucose and insulin concentrations.
Both values are measured in arbitrary units and calculated by the standard trapezoid method.
Incremental AUC is the baseline corrected output for total AUC.
Comparison will be made between group averages at baseline and post-intervention
Measured: Measured on Day 0 and Day 56
Health related quality of life questionnaire
Change in score in health-related quality of life questionnaire General health is ranked on a scale of excellent, very good, good, fair and poor with scores ranging from 1 - 5 respectively.
Volunteers are asked to write the relevant days they have been affected by:
physical health, mental health or impaired by poor mental and physical health, or pain over the last 30 days.
Participants are asked to respond to the following questions relating to the past 30 days:
how many days have they felt sad/blue, worried/tense/anxious, did not have enough rest/sleep and have felt very healthy and full of energy.
Each category will be individually compared at baseline and post-intervention.
Measured: scored on Day 0 and 56
Small intestinal fermentation
Change in Breath test assessment of hydrogen and methane levels (given in ppm - parts per million) and faecal pH (using standard pH meter)
Measured: measured on Days 0, 14 and 56
Faecal pH
Change in Faecal pH, using standard pH meter - Scale 0-14
Measured: measured at day 0 and 56
Faecal moisture content
proportion of faeces (in the percentage of total weight) made up of water
Measured: measured at day 0 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start13 Mar 2019
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stratified single arm study
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- A. Vogel
- Responsible party
- Sponsor
- Investigators
- Alexandra M Johnstone, PhD, Principal investigator, University of AberdeenKaren P Scott, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844152
- Sponsor's protocol ID
- 808
- Acronym
- RIGHTWHEY
- Status last verified
- Nov 2020
- First submitted
- 29 Jan 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Fermented Whey Concentrate on Gut Microbial Activity: Does Butyrate Matter?
- ClinicalTrials.gov ID
- NCT03844152
- Acronym / sponsor ID
- RIGHTWHEY / 808
- Conditions
- Health, Subjective, Healthy, Microbial Colonization
- Keywords
- fermented whey, microbiota, gut health, butyrate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- A. Vogel
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 8-week intervention will investigate the effect of daily consumption of a fermented whey concentrate on the short-chain fatty acid profile of faeces in healthy individuals.
This study will help us understand if consumption of fermented foods rich in lactic acid have a beneficial effect on gut health.
Detailed description
The 8-week dietary supplementation trial will investigate the action of exogenous lactic acid consumption on the activity (using short-chain fatty acid) and composition of the gut microbiota.
Participants will be stratified according to their baseline faecal butyrate levels. Therefore volunteers will be asked to provide two faecal samples one week apart. Based on the average absolute level of butyrate in the faecal samples, volunteers will be stratified into either low, moderate or high baseline butyrate levels (detailed in table 1 below). The levels for faecal butyrate for each group are set based on a meta-analysis of 9 human studies of healthy volunteers carried out at the Rowett Institute (n=116; LaBouyer et al, 2016, unpublished). Thresholds were derived from the boundaries of tertiles. Therefore, the moderate butyrate producers represent the middle 33% (see table). Each stratification arm will have a minimum of 17 study volunteers bringing the total to n=51. This has been set to ensure the completion of at least 45 volunteers. To optimise equal gender distribution amongst all study arms a minimum of 5 females and 5 males will be recruited for each arm.
Stratification Butyrate range Low ≤13 mM Moderate butyrate 13 - 20mM High butyrate ≥20mM
Primary and secondary outcomes will be analysed between the low and high butyrate producing groups as well as the overall group effect on everyone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stratified single arm study
| Arm | Type | Receives |
|---|---|---|
| Fermented whey concentrate | Experimental | Dietary Supplement: Fermented whey concentrateVolunteers will receive the premixed water and fermented whey in weekly deliveries in 1.5L bottles and a drinking glass with a clear indication of the required 200ml volume. Participants will be asked to drink 200 ml of the supplemented water twice daily for the active intervention period. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- i. Men and women aged 18-68 years; BMI ranging from 18-35 kg/m2; measured at the screening visit
Key exclusion criteria (7 listed)
- i. smokers
- ii. subjects with: diagnosis of diabetes, pregnant, hypertension, renal, hepatic, haematological disease, coronary heart disease or any gastrointestinal disorder
- ii. unsuitable veins for blood sampling;
- iii. inability to speak, read and understand English.
- iv. Use of antibiotics within the last 3 months will automatically exclude volunteers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented whey concentrateAlso: MolkosanThe investigated dietary supplement is a form of lacto-fermented whey concentrate (FWC), which has been deproteinised and then diluted (1/20) in sugar-free flavoured water to improve palatability. The main solute within the lacto-fermented whey is L-(+)-lactic acid (7%), produced through bacterial fermentation of the milk sugar lactose. The research team will provide non-descriptive bottles of drink to all volunteers. The flavour of the FWC will be masked by the flavoured water. In order to assess compliance and minimize an initial treatment effect, a 14 day run-in period during which only flavoured water is to be consumed will be completed by all volunteers. At the same time, this period will act as a wash-out, as volunteers will be asked to abstain from the use of any dietary supplements during this period and the rest of the study. The daily energy content of the FWC is 4kcal. | Dietary supplement | Fermented whey concentrate |
Primary outcome
Faecal butyrate concentration - comparing upper and lower tertile of volunteers
Time frame: Baseline measurement (Visit 1) and end of study (visit 3, 8 weeks later) [Baseline butyrate calculated from the average of two values per individual at Day -7 and Day 0; End of study value is the average from two samples collected at Day 49 and 56
Change in relative proportion of butyrate (percentage of total SCFA - sum of propionate, butyrate, acetate, valerate, iso-valerate, iso-butyrate, succinate, lactate mM (millimolar values from gas chromatography) and absolute concentration (mM millimolar) when comparing volunteers as stratified by faecal butyrate levels at start of study. A comparison will be made between the butyrate concentration-dependent groupings.
Faecal butyrate concentration - intervention group effect
Time frame: Baseline measurement (Visit 1) and end of study (visit 3, 8 weeks later) [Baseline butyrate calculated from the average of two values per individual at Day -7 and Day 0; End of study value is the average from two samples collected at Day 49 and 56
Change in relative proportion of butyrate (percentage of total SCFA) and absolute concentration (mM, millimolar) across the total study group
Microbiota composition change
Time frame: Assessed as change between day 0 and day 56
Changes in the composition of the microbiota will be based on next-generation sequence analysis of 16S rRNA (ribosomal ribonucleic acid) genes extracted from faecal samples provided by all volunteers
6 secondary outcomes
Gastrointestinal wellness questionnaire
Time frame: Day 0, 7, 14, 21, 28, 35, 42, 49 and 56
Glucose tolerance and insulin sensitivity
Time frame: Measured on Day 0 and Day 56
Health related quality of life questionnaire
Time frame: scored on Day 0 and 56
Small intestinal fermentation
Time frame: measured on Days 0, 14 and 56
Faecal pH
Time frame: measured at day 0 and 56
Faecal moisture content
Time frame: measured at day 0 and 56
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra M Johnstone, PhD principal investigator
University of Aberdeen
Karen P Scott, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented whey concentrate in people with Health, Subjective and Healthy, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal butyrate concentration - comparing upper and lower tertile of volunteers (time frame: Baseline measurement (Visit 1) and end of study (visit 3, 8 weeks later) [Baseline butyrate calculated from the average of two values per individual at Day -7 and Day 0; End of study value is the average from two samples collected at Day 49 and 56). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.