ObesityNCT04695418
Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women
A study testing Rice Germ in people with Obesity, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Rice Germ
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jan 2018to 27 Dec 2019
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- obesity (BMI 30-40 kg/m2)
- age 50-65
- menopause
- sedentary women and non-smoking,
- women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume)
- women who agreed not to take part in any other weight loss program
Who cannot join
- evidence of heart, kidney or liver disease
- women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder
- taking any medications for weight loss
- control of cholesterol and triglycerides for anti-inflammatory purposes
- pregnancy
- lactating
Show all 9Show fewer
- Type 1 diabetes mellitus, irritable bowel disease, celiac disease, chronic pancreatitis
- antibiotic use in the last three months
- probiotic/prebiotic treatment in the last four weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women: a Pilot Randomized Controlled Clinical Trial
Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety.
- Conditions
- Obesity
- Being tested
- Rice Germ, Placebo
- Keywords
- Rice Germ, Body composition, Amino acids
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice GermDietary supplement
The rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks
PlaceboCombination product
An isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | an isocaloric wheat germ-based supplement Receives: Combination Product: Placebo |
| Rice Germ | Active comparator | Not described Receives: Dietary Supplement: Rice Germ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body composition
free fat mass (g), fat mass (g), visceral abdominal tissue (g)
Measured: Baseline and 4 weeks
Secondary outcomes (14)
Change of amino acid profiles
aspartic acid, glutamic acid, alanine, arginine, asparagine, cysteine, citrulline, phenylalanine, glycine, glutamine, isoleucine, histidine, methylhistidine, methionine, ornithine, serine, tyrosine, threonine, tryptophan, valine (micromol/L)
Measured: Baseline and 4 weeks
Change of biochemical metabolic parameters
total serum cholesterol, triacylglycerol, HDL-cholesterol, LDL-cholesterol, apolipoprotein A, apolipoprotein B, glucose, prealbumin, iron, uric acid, creatinine, electrolytes (mg/dl)
Measured: Baseline and 4 weeks
Change of biochemical metabolic parameters
total proteins (g/dl)
Measured: Baseline and 4 weeks
Change of biochemical metabolic parameters
transaminase alanine aminotransferase, aspartate aminotransferase (IU/L)
Measured: Baseline and 4 weeks
Change of biochemical metabolic parameters
gamma glutamyl transferase, lipase and amylase (U/L)
Measured: Baseline and 4 weeks
Change of biochemical metabolic parameters
Homocysteine (micromol/L)
Measured: Baseline and 4 weeks
Change of biochemical metabolic parameters
Vitamin D and folic acid (ng/mL)
Measured: Baseline and 4 weeks
Change of biochemical metabolic parameters
Vitamin B12 (pg/ml)
Measured: Baseline and 4 weeks
Change of inflammation markers
C- Reactive protein (mg/dl)
Measured: Baseline and 4 weeks
Change of insulin resistance
Homeostasis Model Assessment (HOMA) index
Measured: Baseline and 4 weeks
Change of satiating capacity
Haber score (point scale)
Measured: Every day for 4 weeks
Change of anthropometric measures
weight (kg)
Measured: Baseline and 4 weeks
Change of anthropometric measures
Body mass index (Kg/m2)
Measured: Baseline and 4 weeks
Change of anthropometric measures
calf circumference, waist circumference, arm circumference, hip circumference (cm)
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start28 Jan 2018
- Primary completion2 Dec 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695418
- Sponsor's protocol ID
- 1402/22052019
- Status last verified
- Jan 2021
- First submitted
- 29 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- 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 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women: a Pilot Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04695418
- Acronym / sponsor ID
- 1402/22052019
- Conditions
- Obesity
- Keywords
- Rice Germ, Body composition, Amino acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 5 Jan 2021 (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.
Rice germ (RG) may be a safe and effective dietary supplement for obesity in menopause, considering its high protein content and considerable amounts of essential amino acids, good fatty acids, and fiber. This pilot randomized, blinded, parallel group, placebo-controlled pilot trial investigated the effectiveness of four weeks of RG supplementation (25 g twice a day) on body composition, measured by Dual Energy X-Ray Absorptiometry (DXA), as primary outcome, and metabolic parameters, amino acid profiles and satiating capacity, as secondary outcomes, in obese postmenopausal women following a tailored hypocaloric diet (25-30% less than daily energy requirements). Twenty-seven women were randomly assigned to the supplemented group (14) or placebo group (13). There was a significant interaction between time and group for body mass index (BMI) (p<0.0001), waist (p=0.002), and hip circumference (p=0.01), total protein (0.008), albumin (0.005), Homeostasis Model Assessment index (p=0.04), glycine (p=0.002), glutamine (p=0.004), and histidine (p=0.007). Haber's means over time showed a clearly greater feeling of satiety for the supplemented compared to the placebo group. These findings indicate that RG supplementation in addition to a tailored diet counterbalanced the metabolic changes typical of menopause, with improvements in BMI, body composition, insulin resistance, amino acid profiles and satiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Combination Product: Placeboan isocaloric wheat germ-based supplement |
| Rice Germ | Active comparator | Dietary Supplement: Rice Germ |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- obesity (BMI 30-40 kg/m2)
- age 50-65
- menopause
- sedentary women and non-smoking,
- women who did not drink more than six glasses (one glass: 125 mL) of wine a week and did not drink hard liquor (alcohol content at least 20% alcohol by volume)
Key exclusion criteria (9 listed)
- evidence of heart, kidney or liver disease
- women who met the Diagnostic and Statistical Manual-IV (DSM-V) criteria for a current diagnosis of major depressive disorder
- taking any medications for weight loss
- control of cholesterol and triglycerides for anti-inflammatory purposes
- pregnancy
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 |
|---|---|---|
| Rice GermThe rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks | Dietary supplement | Rice Germ |
| PlaceboAn isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks | Combination product | Placebo |
Primary outcome
Change of body composition
Time frame: Baseline and 4 weeks
free fat mass (g), fat mass (g), visceral abdominal tissue (g)
14 secondary outcomes
Change of amino acid profiles
Time frame: Baseline and 4 weeks
Change of biochemical metabolic parameters
Time frame: Baseline and 4 weeks
Change of biochemical metabolic parameters
Time frame: Baseline and 4 weeks
Change of biochemical metabolic parameters
Time frame: Baseline and 4 weeks
Change of biochemical metabolic parameters
Time frame: Baseline and 4 weeks
Change of biochemical metabolic parameters
Time frame: Baseline and 4 weeks
Change of biochemical metabolic parameters
Time frame: Baseline and 4 weeks
Change of biochemical metabolic parameters
Time frame: Baseline and 4 weeks
Change of inflammation markers
Time frame: Baseline and 4 weeks
Change of insulin resistance
Time frame: Baseline and 4 weeks
Change of satiating capacity
Time frame: Every day for 4 weeks
Change of anthropometric measures
Time frame: Baseline and 4 weeks
Change of anthropometric measures
Time frame: Baseline and 4 weeks
Change of anthropometric measures
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice Germ in people with Obesity, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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 6 inclusion and 9 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 5 Jan 2021. 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 Italy. 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?
Change of body composition (time frame: Baseline and 4 weeks). 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 Jan 2021.