MedPath

Effects of 8 Weeks of Turmeric Ingestion on Physiology and Wellbeing in Healthy Older Adults

Not Applicable
Recruiting
Conditions
Turmeric
Placebo
Registration Number
NCT07196514
Lead Sponsor
Nottingham Trent University
Brief Summary

Curcumin (a bioactive compound found in turmeric) has demonstrated anti-inflammatory and antioxidant properties, and there is evidence to suggest that it may produce improvements in quality of life and markers of health in humans with various conditions. To date, the research has often focussed on the effects of curcumin in human participants with a particular condition. However, turmeric contains hundreds of other bioactive compounds (including other curcuminoids and essential oils) and may be able to benefit a wide range of older adults. Therefore, the aim of this study is to investigate the effects of twice daily consumption of a turmeric beverage for 8-weeks on the physiology and wellbeing of older adults (versus placebo).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
80
Inclusion Criteria

- Body Mass Index between 18.5-35.

Exclusion Criteria
  • History of, or currently diagnosed with, a cardiovascular disease.
  • Diagnosed with diabetes.
  • Diagnosed with a liver, lung, or kidney disease.
  • Diagnosed with osteoporosis.
  • Diagnosed with dementia.
  • Diagnosed with cancer.
  • Use of medications/supplements/herbal remedies with human evidence of a significant interaction with turmeric.
  • Allergy to turmeric, lemon, black pepper, watermelon, water, pineapple, magnesium or vitamin C.
  • Pregnant, attempting to become pregnant, or breastfeeding.
  • Regular (once per week or more) use of turmeric shots / supplements within the last 3 months.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Plasma/serum Brain-derived neurotrophic factorTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using ELISA. We will analyse raw and percentage change values.

Plasma/serum total cholesterolTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Chalder Fatigue Scale (CFS)Two timepoints: 1) baseline 2) after 8 week intervention

This questionnaire measures participants' severity of physical and mental fatigue. This will be scored "Likert style" from 0-33. Higher scores indicate greater levels of fatigue.

Secondary Outcome Measures
NameTimeMethod
McGill Pain QuestionnaireTwo timepoints: 1) baseline 2) after 8 week intervention

This questionnaire is used to evaluate a person experiencing significant pain. It can be used to monitor pain over time. Someone experiencing no pain would score 0 while the maximum score for pain would be 78.

Plasma/serum ASTTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Plasma/serum LDL cholesterolTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Plasma/serum HDL cholesterolTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Plasma/serum ALPTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Plasma/serum ALTTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Plasma/serum creatinineTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Depression Anxiety Stress Scales - 21 items (DASS-21)Two timepoints: 1) baseline 2) after 8 week intervention

Participants choose from a range of questions designed to measure the severity of a range of symptoms common to both depression and anxiety. Scoring is based on a likert scale where higher scores relate to increased severity of depression, anxiety and stress.

36-Item Short Form Survey (SF-36)Two timepoints: 1) baseline 2) after 8 week intervention

This survey consists of generic questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. To score the survey, firstly, responses to items relate to scores between 0-100. Secondly, using a table, items in the same scale are averaged together to create the eight domains.

Serum GGTTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Plasma/serum LDHTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Pittsburgh Sleep Quality Index (PSQI)Two timepoints: 1) baseline 2) after 8 week intervention

The PSQI is a tool used for assessing quality and disturbances over a one-month period. The sum of scores for the following 7 components, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime function, are used to calculate a global PSQI score with scores greater than 5 indicating poor sleep quality.

Plasma/serum creatine kinaseTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Plasma/serum triglyceridesTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values

N-back task for working memory (cognitive function)Two timepoints: 1) baseline 2) after 8 week intervention

This particular N-back tast comprises of only the 2-Back memory load. The total stimulus set is 15. Participants respond using the space bar when they see a stimulus that is presented two steps previously. There are three blocks consisting of 25 trials. Each stimulus will be presented for 500 ms and get 3 seconds to respond unless the participant responds earlier in which case the next trial will begin. Errors, correct responses, misses and reaction time, will be used as indices of performance. Commission errors or 'false alarms' occur when participants respond to non-targets.

Corsi forward block test for visuospatial working memory (cognitive function)Two timepoints: 1) baseline 2) after 8 week intervention

Participants are shown squares/blocks that light up one-by-one in a random order starting in a sequence length of two blocks. Participants then click with the mouse the blocks in exactly the same order as shown before. One extra square is added to each successfully completed sequence. If the participant fails to click the correct sequence they get one more chance with a different pattern and same sequence length. If they get it wrong again, the test ends and their score is shown (the corsi block span).

Corsi backward block test for visuospatial working memory (cognitive function)Two timepoints: 1) baseline 2) after 8 week intervention

This test is the reverse of the forward version. Participants are shown squares/blocks that light up one-by-one in a random order starting in a sequence length of two blocks. Participants then click with the mouse the blocks in the reverse order as shown before. One extra square is added to each successfully completed sequence. If the participant fails to click the correct sequence, they get one more chance with a different pattern and same sequence length. If they get it wrong again, the test ends and their score in shown (the corsi block span).

Plasma/serum C-reactive proteinTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values.

Plasma/serum glucoseTwo timepoints: 1) baseline 2) after 8 week intervention

Measured using pentra C400 clinical chemistry analyser, We will analyse raw and percentage change values

Blood pressureTwo timepoints: 1) baseline 2) after 8 week intervention

Systolic and diastolic blood pressure will be determined using an automatic upper arm blood pressure monitor. We will analyse raw and percentage change values.

Body massTwo timepoints: 1) baseline 2) after 8 week intervention

Determined by weighing participants.

Sit-to-Stand TestTwo timepoints: 1) baseline 2) after 8 week intervention

The objective of this test is to complete as many sit-to-stand repetitions as possible in 30 seconds. Participants will be instructed to sit in the middle of a chair placed against the wall with a seat height of 43 cm. Participants start with their feet flat on the floor, arms crossed at the wrists and held against the chest. On the signal, participants will rise to a full stand and return back to a fully seated position (counting as one full repetition). Before the test, participants will be allowed to practice 1-2 times to familiarise themselves with the movement

Hand Grip Strength TestTwo timepoints: 1) baseline 2) after 8 week intervention

Participants will start by holding a hand grip dynamometer with their arm at a right angle and the elbow should be by the side of the body. The grip length will be noted and kept the same post intervention laboratory visit. Once the participant has a comfortable grip on the dynamometer they will squeeze the dynamometer with maximum isometric effort and maintain it for at least 5 seconds. No other body movement is allowed. The value shown on the dynamometer in kilograms will be recorded. Participants will alternate hands attempting the test three times with each hand.

2-minute Step TestTwo timepoints: 1) baseline 2) after 8 week intervention

The objective of this test is to complete as many steps (with the knee reaching the marking) in 2-minutes as possible. To mark the line for the knee to cross, the distance between participant's anterior iliac crest and their patella will be measured and the midpoint will be found. A piece of tape will be placed on the stadiometer corresponding height of the midpoint between the patella and the iliac crest. The final score will be the number of times the right knee reached the tape height.

Waist circumferenceTwo timepoints: 1) baseline 2) after 8 week intervention
Waist to hip ratioTwo timepoints: 1) baseline 2) after 8 week intervention
Physical activity levelsTwo one week periods: first week of intervention (week 1) and last week of intervention (week 8)

A wrist monitor will allow for classifications of physical activity intensities (sedentary behaviour, light intensity physical activity, moderate intensity physical activity, moderate-vigorous intensity physical activity and vigorous intensity physical activity) and durations of time spent in these classifications.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Two timepoints: 1) baseline 2) after 8 week intervention

Participants that have osteoarthritis will complete this questionnaire. The highest possible score is 96, which indicates the maximum pain, stiffness and difficulty with physical function.

Trial Locations

Locations (1)

Nottingham Trent University, Clifton campus

🇬🇧

Nottingham, United Kingdom

Nottingham Trent University, Clifton campus
🇬🇧Nottingham, United Kingdom
John Hough
Contact
+441158483970
John.Hough@ntu.ac.uk

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