The Effect on Micronutrient Status of a Diet of 100% Huel

NCT04734938 | Completed

• 1 other identifier: 2003/4657
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This project will assess the effect of Huel Food replacement on the micronutrient status of healthy volunteers over a 4-week period. To achieve this, 30 (non-smoking) generally healthy volunteers will be recruited to attend the study centre on three separate occasions. Volunteers will be asked to consume their normal diet for one week whilst recording what they eat. They will then be asked to only consume Huel Powder and water for 4 weeks.

Conditions

Micronutrients

Keywords

Micronutrients

Outcome Measures

Primary Outcomes (12)

• Change in level of calcium, cholesterol status, haemoglobin, magnesium, sodium, potassium in blood

  Change in the level of alcium, cholesterol status, haemoglobin, magnesium, sodium, potassium in blood (mmol/l)

  week 0 and week 1

• Change in level of calcium, cholesterol status, haemoglobin, magnesium, sodium, potassium in blood

  Change in the level of calcium, cholesterol status, haemoglobin, magnesium, sodium, potassium in blood (mmol/l)

  week 1 and week 5

• Change in level of HbA1c in blood

  Change in the level of HbA1c in blood (mmol/mol)

  week 0 and week 1

• Change in level of HbA1c in blood

  Change in the level of HbA1c in blood (mmol/mol)

  week 1 and week 5

• Change in level of choline, copper, Iron status, selenium, Vitamin A, Vitamin C, Vitamin E, Vitamin D and Zinc

  Change in the level of choline, copper, Iron status, selenium, Vitamin A, Vitamin C, Vitamin E, Vitamin D and Zinc in blood (micro mol/l)

  week 0 and week 1

• Change in level of choline, copper, Iron status, selenium, Vitamin A, Vitamin C, Vitamin E, Vitamin D and Zinc

  Change in the level of choline, copper, Iron status, selenium, Vitamin A, Vitamin C, Vitamin E, Vitamin D and Zinc in blood (micro mol/l)

  week 1 and week 5

• Change in level of manganese and Folate

  Change in the level of manganese and Folate in blood (nmol/l)

  week 0 and week 1

• Change in level of manganese and Folate

  Change in the level of manganese and Folate in blood (nmol/l)

  week 1 and week 5

• Change in level of Vitamin B12

  Change in the level of Vitamin B12 in blood (pmol/l)

  week 0 and week 1

• Change in level of Vitamin B12

  Change in the level of Vitamin B12 in blood (pmol/l)

  week 1 and week 5

• Change in level of Thyroid Stimulating Hormone (TSH)

  Change in the level of THS in blood (mU/l)

  week 0 and week 1

• Change in level of Thyroid Stimulating Hormone (TSH)

  Change in the level of THS in blood (mU/l)

  week 1 and week 5

Secondary Outcomes (8)

• Change in BMI

  Week 0 and week 1

• Change in BMI

  week 1 and week 5

• Change in Weight

  Week 0 and week 1

• Change in Weight

  week 1 and week 5

• Change in hip to waist ratio

  Week 0 and week 1

Study Arms (2)

Habitual Diet

NO INTERVENTION

All volunteers will participate in this arm, continuing this habitual diet for 1 week

100% Huel

EXPERIMENTAL

All volunteers will participate in this arm of the study and consumer 100% Huel as their food for 4 weeks

Dietary Supplement: Huel Powder

Interventions

Huel Powder DIETARY_SUPPLEMENT

Huel is made of an ultra-fine blend of sustainable ingredients. Oats, rice, peas, coconut, flaxseed, and our unique mix of vitamins and nutrients to provide you a meal with all the carbohydrates, protein, essential fats, fibre, and all the 26 essential vitamins and minerals your body needs to thrive. Volunteers will consume only Huel as their food source for the final four weeks of the study.

100% Huel

Eligibility Criteria

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

You may qualify if:

• generally health (includes not having been diagnosed with any eating disorders and not receiving regular medication other than contraceptives or statins)
• years or older,
• non-pregnant,
• non-lactating
• non-smoking,
• no known food allergies.

You may not qualify if:

• \*taking medication for long term illnesses such as high blood pressure, heart disease, or medication that affects liver or kidney function.

Sponsors & Collaborators

• Newcastle University: lead

Study Sites (1)

Newcastle University

Newcastle, Tyne and Wear, NE2 4HH, United Kingdom

Location

Study Officials

• Jeffrey Pearson, PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label crossover trial

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: February 2, 2021
• Study Start: October 19, 2020
• Primary Completion: July 29, 2021
• Study Completion: October 28, 2021
• Last Updated: May 13, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)