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ObesityNCT04904601

Freeze-dried Kale to Reduce Metabolic Risk in Saudi Subjects

A study testing Kale supplement and Peas supplement in people with Obesity and Metabolic Disease, run by Chair for Biomarkers of Chronic Diseases at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Whilst obesity represents a key risk factor for the development of metabolic disease and further premature mortality, the actual type of diet may provide the 'primary insults' for inflammation affecting systemic health in the pre-diabetic state such as obesity. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Metabolic Disease
What is being tested?
Kale supplement and Peas supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteSaudi Arabia
Study dates
15 Sep 2021to 28 Sep 2022
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Obese (BMI 30-40Kg/m2 and above)
  • Aged 18-40 years
  • Saudi nationality
  • Female

Who cannot join

  • Age under 18 or above 40 years
  • Any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome)
  • Those with chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulatory like cyclosporine, azathioprine; severe depression or any psychiatric illness, claustrophobia or needle phobia.
  • Males
  • Expatriates

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Community Health Department, Applied Medical Sciences, King Saud University

    Riyadh, Riyadh Region, 11451

Other trials in Saudi Arabia

About this study

Official title: Acute and Medium Effects of Freeze-dried Kale to go, New Superfood Supplement to Reduce Metabolic Risk in Saudi Subjects

Whilst obesity represents a key risk factor for the development of metabolic disease and further premature mortality, the actual type of diet may provide the 'primary insults' for inflammation affecting systemic health in the pre-diabetic state such as obesity. Specifically, previous data indicate that a high-fat diet and/or unfavorable systemic lipid profiles can impair metabolic health which may occur via inflammatory mechanisms. The study aims to conduct a randomized interventional dietary trial with Freeze-dried Kale, as a superfood, to reduce inflammation and improve lipid profile in patients with obesity. These studies will analyze the effects of this superfood on metabolic changes among obese and non-obese Saudi women. Our hypothesis is the inclusion of Brassica into the daily diet will significantly improve metabolic health, microbiota composition, lower inflammatory insults (inflammasome), and lower microbial translocation, with resulting improvements in metabolic health. The team, therefore, proposes to examine the impact of the superfood kale on lipid function (acute and medium-term) over a 4 week dietary intervention period to assess the influence on metabolic change and biomarker changes. The team intends to utilize the expertise from a broad spectrum of specialists from plant biologists, clinical and allied health care professionals, and translational scientists, to provide a unique holistic insight into the role of nutrition for metabolic health benefits in human participants. These studies will provide us with the capacity to use a directly applicable dietary supplement, freeze-dried Kale, to improve the health of people metabolically. As this is a natural product, this will have the capability to reach the market much quicker and advance research at a much faster pace. This dietary supplement will also provide an additional measure to improve the health across the general public not just those at increased risk of disease to help provide another way to improve health among Saudis.

Read the detailed description

Subjects Selection:

For this study we will recruit a total of 100 obese age matched non-diabetic Saudi women, (age 18-40 years; BMI 30-40Kg/m2) through college clinics in applied medical sciences college, KSU. The study participants exclusion criteria in brief: age under 18 or above 40 years, any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome); chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulatory like cyclosporine, azathioprine; severe depression or any psychiatric illness, claustrophobia or needle phobia.

Sample and Data Collections:

Anthropometry and body composition as well as biochemical data will be undertaken for all visits, including blood, urine and stool collection. Serum will be collected all patients for later analysis. All samples collected will be stored appropriately for biochemical analysis within the Bio-Bank facilities, in the Chair for Biomarkers of Chronic Diseases in King Saud University. All samples will be stored at -80oC following the appropriate protocol extraction methods.

Intervention:

Participants will be randomized to give either Kale (blanched freeze dried Kale) group1 or placebo (Blanched Freeze dried Peas) group2. The supplements will be given as one scoop of powder of (Kale or Green Peas) three times a day for a total of 10g/day. The follow up will be for 6 week intervention. After visit 2 will be washout period for 2 weeks, to study acute and medium effects, followed by a cross-over between the groups.

Being tested
Kale supplement, Peas supplement
Keywords
Kale supplement, Microbiome, Obesity, Endotoxin
Medical subject headings
Obesity, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kale supplementDietary supplement

    Kale (blanched freeze-dried Kale) group1

  • Peas supplementDietary supplement

    placebo (Blanched Freeze-dried Peas) group2

Study groups in NCT04904601
Study groupRoleWhat they receive
Experimental Group: KaleActive comparatorThis group will be given one scoop of powder of (Kale) three times a day for a total of 10g/day for 6 weeks.
Receives: Dietary Supplement: Kale supplement
Placebo Group: Green PeasPlacebo comparatorThis group will be given one scoop of powder of (Green Peas) three times a day for a total of 10g/day for 6 weeks.
Receives: Dietary Supplement: Peas supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study the acute-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women

    Differences in characteristics of total cholesterol (mmol/l), hdl-cholesterol (mmol/l), ldl-cholesterol (mmol/l) and triglycerides (mmol/l) at baseline and subsequent follow ups.

    Measured: 2 weeks

  2. Study the medium-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women

    Differences in characteristics of total cholesterol (mmol/l), hdl-cholesterol (mmol/l), ldl-cholesterol (mmol/l) and triglycerides (mmol/l) at baseline and subsequent follow ups.

    Measured: 4 weeks

Secondary outcomes (7)

  1. Study the acute and medium term effects of Kale Superfood on BMI

    Differences in body mass index (BMI, kg/m2) at baseline and subsequent follow-ups

    Measured: 6 weeks

  2. Study the acute and medium term effects of Kale Superfood on glucose levels

    Differences in fasting glucose (mmol/l), at baseline and subsequent follow-ups

    Measured: 6 weeks

  3. Study the acute and medium term effects of Kale Superfood on alanine aminotransferase levels

    Differences in alanine aminotransferase (ALT, U/L)at baseline and subsequent follow-ups

    Measured: 6 weeks

  4. Study the acute and medium term effects of Kale Superfood on aspartate aminotransferase levels

    Differences in aspartate aminotransferase (AST, U/L) at baseline and subsequent follow-ups

    Measured: 6 weeks

  5. Study the acute and medium term effects of Kale Superfood on HbA1c levels

    Differences in Hemoglobin A1c (Hba1C, %), at baseline and subsequent follow-ups

    Measured: 6 weeks

  6. Study the acute and medium term effects of Kale Superfood on insulin levels

    Differences in insulin (IU/ml) at baseline and subsequent follow-ups

    Measured: 6 weeks

  7. Study the acute and medium term effects of Kale Superfood on C-peptide levels

    Differences in C-peptide levels (nmol/L) at baseline and subsequent follow-ups

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start15 Sep 2021
  3. Primary completion28 Sep 2022
  4. Study completion28 Sep 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Kale (blanched freeze-dried Kale) group 1 (N=50 adult obese Saudi women) Placebo (Blanched Freeze-dried Peas) group 2 (N=50 adult obese Saudi women)
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04904601
Sponsor's protocol ID
20121503
Status last verified
Feb 2025
First submitted
18 Apr 2021
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Kale supplement and Peas supplement in people with Obesity and Metabolic Disease, run by Chair for Biomarkers of Chronic Diseases at 1 site in Saudi Arabia.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Feb 2025. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Study the acute-term effects of freeze-dried Kale in lipid profile of obese, non-T2DM women (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04904601.

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 13 Feb 2025.

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