Cobden Research - Consultants on omega fatty acids for human nutrition COBDEN RESEARCH LIMITED
Leading authority on the production and use
of essential fatty acids in human nutrition

Clinical Trials

For 10 years Peter Clough was responsible for managing the clinical trials programme for Efamol Ltd., a UK-based manufacturer of nutritional supplements. This involved co-ordinating activities with research groups, universities, hospitals and other institutions, working with essential fatty acids internationally in the UK, Europe, Australia, New Zealand, and Singapore. These projects have been either directly funded (wholly or partly) by Efamol Ltd, or by national research councils or government agencies. During that time he has had an active involvement in approximately 20 projects ranging in size from 50 subjects to 2500 subjects. Clinical areas of interest have included maternal and infant nutrition, child development and learning, memory and cognitive function in young and elderly adults, sickle cell disease and skin health.

Peter Clough is therefore well prepared to offer advice and assistance in the following areas:

  • Technical advice on trial design and test material formulations

  • Identifying and liaising with suitable partner institutions, laboratories and manufacturers

  • Defining trial objectives and protocols

  • Managing trials on behalf of commercial partners

  • Specifying and formulating active and placebo test materials and managing their manufacture and supply

  • Interpretation of clinical findings to assist in product positioning, marketing and registration

Recent clinical trials on which Peter Clough has acted as an advisor or co-ordinator include:

  • Evaluation of a novel GLA-rich moisturising oil on healthy normal skin (UK)

  • Prevention of pre-term delivery by nutritional supplementation in pregnancy (Australia)

  • Assessment of the evolution of cognitive decline with DHA supplementation versus a control (Spain)

  • Effects of omega-3 fatty acid supplementation on measures of frailty in the elderly (UK)

  • The impact of fish and fish oil capsule intake on omega-3 fatty acid status, health and cognitive function of Omani school children (Oman)

  • Docosahexaenoic acid supplementation to improve maternal, foetal and infant outcomes (Sudan)

Published Trial Reports

Acknowledgment (personal or corporate) of contribution to published clinical trials in which Peter Clough has been involved can be found in :

Al-Ghannami SS, et al.
Lipid soluble nutrient status of healthy Omanu school children before and after intervention with oily fish meal or re-esterified triacylglycerol fish oil.
Nutrition (2016) 36:73–8

Jackson PA, et al.
DHA supplementation alone or in combination with other nutrients does not modulate cerebral hemodynamics or cognitive function in healthy older adults.
Nutrients (2016) 8(2):86

Strike SC, et al.
A high omega-3 fatty acid multinutrient supplement benefits cognition and mobility in older women: a randomized, double-blind, placebo-controlled pilot study.
Journal of Gerontology (2016) 71(2):236-42

Daak AA, et al.
Docosahexaenoic and eicosapentaenoic acid supplementation does not exacerbate oxidative stress or intravascular haemolysis in homozygous sickle cell patients.
PLEFA (2013) 89(5):305-11

Daak AA, Ghebremeskel K, Hassan Z, Attallah B, Azan HH, Elbashir MI, Crawford M
Effect of omega-3 (n-3) fatty acid supplementation in patients with sickle cell anemia: randomized, double-blind, placebo-controlled trial.
Am J Clin Nutr (2013) 97:1-8

Long S-J and Benton D
A double-blind trial of the effect of docosahexaenoic acid and vitamin and mineral supplementation on aggression, impulsivity, and stress.
Hum Psychopharmacol Clin Exp (2013) Published online in Wiley Online Library ( DOI: 10.1002/hup.2313

Stonehouse W, Conlon C, Podd J, Hill SR, Minihane AM, Haskell C, Kennedy D
Docosahexaenoic acid supplementation improved both memory and reaction time in healthy young adults: A randomized controlled trial.
Am J Clin Nutr (2013) Published online March 20, 2013 doi:10.3945/ajcn.112.053371

Palmer DJ, Sullivan T, Gold MS, Prescott SL, Heddle R, Gibson RA, Makrides M
Effect of n-3 long chain polyunsaturated fatty acid supplementation in pregnancy on infants' allergies in first year of life: randomised controlled trial.
BMJ (2012) 344:e184 doi:10.1136/bmj.e184

Makrides M, Gibson R, McPhee A, Yelland L, Quinlivan J et al.
Effect of DHA supplementation during pregnancy on maternal depression and neurodevelopment of young children.
JAMA (2010) 304(15):1675-83

Zaalberg A et al.
Effects of Nutritional Supplements on Aggression, Rule-Breaking and Psychopathology among Young Adult Prisoners.
Aggressive Behaviour (2010) 36:117-26

Muggli R
Natural management of napkin rash.
Eur J Pediat Dermatol (2009) 19:43-6

Meguid NA et al.
Role of polyunsaturated fatty acids in the management of Egyptian children with autism,
Clin Biochem (2008) doi:10.1016/j.clinbiochem.2008.05.013

Geppert J et al.
Co-supplementation of healthy women with fish oil and evening primrose oil increases plasma docosahexaenoic acid, g-linolenic acid and dihomo-glinolenic acid levels without reducing arachidonic acid concentrations.
British Journal of Nutrition (2007)

Morse NL and Clough P
A meta-analysis of randomized, placebo-controlled clinical trials of Efamol® evening primrose oil in atopic eczema. Where do we go from here in light of more recent discoveries?
Current Pharmaceutical Biotechnology (2006) 7:503-24

Muggli R
Systemic evening primrose oil improves the biophysical skin parameters of healthy adults.
International Journal of Cosmetic Science (2005) 27:243-9