Clinical trial NCT04695418: Effectiveness of Rice Germ Supplementation on Body Composition, Metabolic Parameters, Satiating Capacity and Amino Acid Profiles in Obese Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Rice Germ
Body composition
Amino acids
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 27
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Change of body composition
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change of amino acid profiles
timeFrame: Baseline and 4 weeks
measure: Change of biochemical metabolic parameters
timeFrame: Baseline and 4 weeks
measure: Change of biochemical metabolic parameters
timeFrame: Baseline and 4 weeks
measure: Change of biochemical metabolic parameters
timeFrame: Baseline and 4 weeks
measure: Change of biochemical metabolic parameters
timeFrame: Baseline and 4 weeks
measure: Change of biochemical metabolic parameters
timeFrame: Baseline and 4 weeks
measure: Change of biochemical metabolic parameters
timeFrame: Baseline and 4 weeks
measure: Change of biochemical metabolic parameters
timeFrame: Baseline and 4 weeks
measure: Change of inflammation markers
timeFrame: Baseline and 4 weeks
measure: Change of insulin resistance
timeFrame: Baseline and 4 weeks
measure: Change of satiating capacity
timeFrame: Every day for 4 weeks
measure: Change of anthropometric measures
timeFrame: Baseline and 4 weeks
measure: Change of anthropometric measures
timeFrame: Baseline and 4 weeks
measure: Change of anthropometric measures
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
References: